Bakri G30673Recalls & reported problems

Summary

The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 10827002306735), received between May 12, 2016 and Aug 21, 2025 — classified as 40 injuries, 315 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (200 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 355 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY, A PINHOLE LEAK WAS FOUND IN 'BAKRI TAMPONADE BALLOON CATHETER'. THE PATIENT LOST 460 ML OF BLOOD DURING A CESAREAN SECTION. THE PHYSICIAN PLACED THE BALLOON TO FILL IT WITH WATER, AND THE BLOOD WAS STILL FLOWING FROM THE VAGINAL OPENING. THE PHYSICIAN IMMEDIATELY DEFLATED THE BALLOON AND REMOVED IT TO FIND THAT THE BALLOON HAD "THREE NEEDLE-TIP-LIKE LEAKS". THE PHYSICIAN REPORTED THAT AN EDENTULOUS OVAL FORCEPS WAS USED FOR PLACEMENT AND THAT THE NEEDLE TIP WAS NOT "TOUCHED" DURING THE OPERATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER BALLOON. REPORTEDLY, THE PATIENT LOST A TOTAL OF 560 ML BLOOD AND DID NOT REQUIRE A BLOOD TRANSFUSION. A SECTION OF THE BALLOON DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22859987 ↗
• MalfunctionAug 20, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  AS REPORTED, DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY, THE CATHETER AND VALVE SPIRAL INTERFACE OF 'BAKRI TAMPONADE BALLOON CATHETER' WAS LOOSE. AS REPORTED, THE MATERNAL BLEEDING AFTER CESAREAN SECTION EXCEEDED 700 ML. THE PHYSICIAN USED THE BALLOON TO STOP THE BLEEDING OF THE PATIENT. REPORTEDLY, THE CATHETER AND VALVE SPIRAL INTERFACE WAS VERY LOOSE AND CAME OFF EASILY WHEN THE BALLOON WAS INJECTED WITH LIQUID. THE BALLOON WAS NOT REPLACED AND THE PROCEDURE WAS COMPLETED "CAREFULLY". POSTOPERATIVELY, THE CONDITION OF THE PATIENT WAS MONITORED CLOSELY. SUBSEQUENTLY, THE BALLOON WAS REMOVED AT NOON NEXT DAY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854011 ↗
• MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING TREATMENT OF POSTPARTUM HEMORRHAGE, SECONDARY TO UTERINE ATONY, THE 'BAKRI TAMPONADE BALLOON CATHETER' LEAKED. THE ISSUE WAS IDENTIFIED WHEN SALINE WAS INJECTED TO CHECK THE INTEGRITY OF THE WELL PACKED BALLOON CATHETER BEFORE TRANSVAGINAL PLACEMENT. REPORTEDLY, BLOOD LOSS PRIOR TO FAILURE IS UNKNOWN SINCE THE BALLOON WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING WITH AN UNSPECIFIED NEW BALLOON. REPORTEDLY, THE POSTOPERATIVE TOTAL BLEEDING WAS 400 ML WITH NO TRANSFUSION PERFORMED, AND THE FINAL HEMOSTASIS WAS SUCCESSFUL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE OR EXPERIENCE ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833967 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, A BAKRI TAMPONADE BALLOON CATHETER WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH). THE BALLOON WAS PLACED INTO THE PATIENT AND INFLATED WITH 300 ML OF SALINE SOLUTION; AN ULTRASOUND WAS VIEWED ONE HOUR AFTER THE PROCEDURE TO SHOW THAT THE BALLOON WAS LOCATED IN THE LOWER PART OF THE UTERINE CAVITY AND THE WATER SAC WAS FILLED. AT TWENTY-FOUR HOURS AFTER THE PROCEDURE, THE BALLOON WAS READY TO BE REMOVED FROM THE UTERINE CAVITY. THE SYRINGE FAILED TO WITHDRAW THE FLUID FROM THE BALLOON REPEATEDLY, AND THE DOCTOR PULLED THE DRAINAGE TUBE AT THE END OF THE BALLOON, WHICH CAME OUT OF THE UTERINE CAVITY ON ITS OWN. THERE WAS NO SALINE SOLUTION LEFT IN THE BALLOON. THE USER THEN INJECTED 300 ML OF SALINE INTO THE BALLOON, AND IT WAS IN PLACE FOR FOUR HOURS MORE WITHOUT LEAKAGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730349 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' LEAKED DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH). PRIOR TO PLACEMENT THE BALLOON AFTER CESAREAN, UTERINE CONTRACTIONS WERE POOR DUE TO ATONY OF THE LOWER UTERINE SEGMENT, AND THE PATIENT LOST 600 ML OF BLOOD. DURING TRANSVAGINAL EXPLORATION, THE BALLOON WAS PLACED INTO THE UTERINE CAVITY FOR SALINE INJECTION AND LEAKAGE WAS FOUND. THE PATIENT LOST 200 ML OF BLOOD AFTER THE DEVICE FAILURE. TOTAL BLEEDING REPORTED WAS 800 ML. HEMOSTASIS WAS ACHIEVED THROUGH PLACEMENT OF A SECOND BAKRI DEVICE INJECTED WITH FLUID AND COMPRESSION. IT WAS REPORTED THAT THE BALLOON WAS NOT HANDLED IN PROXIMITY OF ANY METAL TOOLS. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556602 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555246 ↗
• MalfunctionJul 10, 2025Material Rupture; Material Rupture

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, THE BAKRI TAMPONADE BALLOON CATHETER'S BALLOON RUPTURED DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 600ML. THE BALLOON WAS THEN PLACED INTO THE PATIENT, BUT IT DID NOT INFLATE AFTER SEVERAL WATER INJECTIONS. UPON INSPECTION, THE BALLOON WAS FOUND TO BE RUPTURED. IT WAS IMMEDIATELY REPLACED WITH A NEW ONE. THE TOTAL ESTIMATED BLOOD LOSS WAS 680ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470188 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413148 ↗
• InjuryJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER A VAGINAL DELIVERY; THE PATIENT LOST ABOUT 600ML OF BLOOD. A BAKRI TAMPONADE BALLOON CATHETER WAS PLACED TRANSVAGINALLY AS TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) THE DEVICE WAS NOT HANDLED BY OR IN THE PROXIMITY OF ANY METAL TOOLS THAT MAY HAVE DAMAGED THE BALLOON. THE USER FOUND THAT THERE WAS A LEAK WHEN INJECTING WATER IN THE BALLOON AND IT COULD NOT BE USED NORMALLY. THE BALLOON WAS REMOVED IMMEDIATELY. THE PATIENT CONTINUED TO LOSE APPROXIMATELY 900ML OF BLOOD. TOTAL ESTIMATED BLOOD LOSS OF 1500ML. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THE PATIENT RECEIVED 2 UNITS OF RED BLOOD CELL SUSPENSION, TRANSFUSED WITHIN 30 MINUTES, FOLLOWED BY 600ML OF FRESH FROZEN PLASMA. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346892 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS TO BE USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 400 ML. BEFORE PLACING THE BALLOON, THE INNER AND OUTER PACKAGING WAS INSPECTED PRIOR TO USE AND FOUND TO BE INTACT. PRIOR TO USE, BALLOON INTEGRITY WAS TESTED BY INJECTING SALINE SOLUTION WITH LEAKING NOTED FROM THE BALLOON. THE USER REPLACED THE DEVICE WITH A SIMILAR ONE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE TOTAL ESTIMATED BLOOD LOSS WAS 500 ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335517 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY OF TWINS, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) WITH SIGNIFICANT VAGINAL BLEEDING, SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500 ML. THE BALLOON WAS PLACED INTO THE PATIENT AND INFLATED WITH 500ML SALINE SOLUTION WHEN LEAKING WAS NOTED THROUGH THE VAGINA. UPON REMOVAL, THE BALLOON WAS FOUND TO BE LEAKING. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE PATIENT LOST 100ML OF BLOOD AFTER THE DEVICE FAILURE. THE TOTAL ESTIMATED BLOOD LOSS WAS 600 ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298918 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH). THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 1300 ML. THE BALLOON WAS THEN PLACED INTO THE PATIENT AND INFLATED WITH 180 ML OF SALINE SOLUTION. THE DEVICE WAS FOUND TO BE "ABNORMAL", AND IT WAS REMOVED STILL CONTAINING THE SALINE SOLUTION. LEAKING WAS NOTED AT THE ANTERIOR END OF THE BALLOON CATHETER AND BALLOON JUNCTION. THE BALLOON HAD NOT COME INTO CONTACT WITH ANY METAL TOOLS. ESTIMATED BLOOD LOSS AFTER DEVICE FAILURE WAS 100-150 ML. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213624 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A VAGINAL DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500ML PRIOR TO BALLOON PLACEMENT. THE DOCTOR PLACED THE BALLOON INTO THE PATIENT USING A METAL TOOL. THE BALLOON WAS INFLATED WITH WATER AND LEAKING WAS NOTED. THE PATIENT CONTINUED TO LOSE AN ADDITIONAL 100ML OF BLOOD. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. TOTAL BLOOD LOSS WAS 600ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193297 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200180 ↗
• MalfunctionJan 13, 2025Material Rupture; Material Rupture

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, A BAKRI TAMPONADE BALLOON CATHETER WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH). THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 600 ML AND THE BALLOON WAS THEN PLACED WITH TOOTHLESS OVAL FORCEPS AND INSERTED THROUGH AN ABDOMINAL INCISION. AFTER SEVERAL INJECTIONS OF FLUIDS, THE BALLOON DID NOT INFLATE AND COMPRESS AND IT WAS RETRACTED THROUGH THE VAGINA. A RUPTURE WAS NOTED ON THE UPPER HALF OF THE BALLOON. AFTER THE RUPTURE OF THE BALLOON, THE PATIENT BLED ABOUT 50 ML. THE TOTAL ESTIMATED BLOOD LOSS WAS 700ML. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139852 ↗
• MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, THE PATIENT LOST 500 ML OF BLOOD CAUSED BY POOR CONTRACTION OF THE LOWER SEGMENT OF THE UTERUS AFTER A NORMAL DELIVERY. THE BAKRI TAMPONADE BALLOON CATHETER WAS PLACED VAGINALLY AS TREATMENT OF POSTPARTUM HEMORRHAGE [PPH] AND THEN THE BALLOON WAS INJECTED WITH SALINE SOLUTION TO A VOLUME OF 200 ML. AND FOUND THE BALLOON TO BE LEAKING, WHICH WAS THEN REPLACED WITH A NEW BALLOON AND SUCCESSFULLY STOPPED THE HEMORRHAGE. AFTER THE LEAKAGE OCCURRED, THE PATIENT LOST 400ML OF BLOOD AFTER THE DEVICE FAILURE. FOR A TOTAL ESTIMATED BLOOD LOSS OF 900 ML. THE DEVICE WAS NOT HANDLED BY OR IN THE PROXIMITY OF ANY METAL TOOLS. THE PATIENT DID NOT RECEIVE ANY BLOOD TRANSFUSIONS. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21086186 ↗
• MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED 03FEB2025. THE DEVICE WAS PLACED TRANSVAGINAL.

  Patient problems: Insufficient Information

  MAUDE report 21072033 ↗
• MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, THE BALLOON OF THE BAKRI TAMPONADE BALLOON CATHETER LEAKED DURING THE TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) IN A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT HAD A NORMAL DELIVERY WITH POSTPARTUM HEMORRHAGE DUE TO WEAK CONTRACTIONS (UTERINE ATONY). A BAKRI BALLOON WAS INSERTED INTO THE UTERUS THROUGH THE VAGINA WITH A TOOTHLESS OVAL FORCEPS, BUT AFTER FIVE MINUTES, IT WAS FOUND THAT THERE WAS A LEAKAGE FROM THE BALLOON. THE WATER WAS INJECTED AGAIN BUT THE BALLOON STILL LEAKED. THE DAMAGED BALLOON WAS REMOVED, AND A NEW BALLOON WAS REINSERTED TO GRADUALLY STOP THE BLEEDING. THE BALLOON WAS INFLATED TO 450 MILLILITERS. THE TOTAL ESTIMATED BLOOD LOSS WAS 550 MILLILITERS, OUT OF WHICH, 350 MILLILITERS WAS LOST BEFORE THE DEVICE FAILURE AND 250 MILLILITERS WAS LOST AFTER THE DEVICE FAILURE. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071905 ↗
• InjuryNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, A BAKRI TAMPONADE BALLOON CATHETER WAS USED TO TREAT POST PARTUM HEMORRHAGE (PPH). PRIOR TO DEVICE PLACEMENT, THE PATIENT LOST ABOUT 600 ML OF BLOOD. THE BAKRI WAS PLACED TRANSVAGINALLY AND DID NOT COME IN CONTACT WITH ANY METAL INSTRUMENTS. WATER WAS INJECTED AFTER DEVICE PLACEMENT, AND THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT, FILLED WITH WATER, AND FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763141 ↗
• InjuryNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737441 ↗
• MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CORRECTED INFORMATION RECEIVED 12DEC2024: DATE OF EVENT WAS 30OCT2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736234 ↗
• MalfunctionNov 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20714207 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689650 ↗
• MalfunctionOct 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF A 'BAKRI TAMPONADE BALLOON CATHETER' RUPTURED DURING TREATMENT OF POSTPARTUM HEMORRHAGE, SECONDARY TO PLACENTA PREVIA. THE BALLOON WAS PLACED IN THE PATIENT TRANSVAGINALLY AND INFLATED WITH ~350ML OF SALINE AT WHICH TIME LEAKAGE DUE TO BALLOON RUPTURE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NEW LIKE-DEVICE. THE PATIENT HAD AN ESTIMATED BLOOD LOSS OF 500ML PRIOR TO DEVICE USE AND AN ADDITIONAL 100ML AFTER DEVICE USE; TOTAL ESTIMATED BLOOD LOSS WAS 600ML. THE PATIENT DID NO REQUIRE ANY BLOOD TRANSFUSIONS. THE DEVICE WAS NOT TESTED PRIOR TO USE AND WAS NOT HANDLED BY OR IN THE PROXIMITY OF ANY METAL TOOLS THAT MAY HAVE DAMAGED THE BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539927 ↗
• InjuryOct 21, 2024Component Missing; Component Missing

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494031 ↗