BioFlo 02-803Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI H965103028030), received between Jul 24, 2018 and Jan 16, 2025 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MERIT MEDICAL NOTIFIED ANGIODYNAMICS OF A COMPLAINT RECEIVED FROM AN END USER REGARDING A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 24CM DURAMAX KIT. THE CUSTOMER REPORTS THE DEVICE WAS LEAKING. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR RETURN (WAS REMOVED). NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168367 ↗
• MalfunctionJan 16, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MERIT MEDICAL NOTIFIED ANGIODYNAMICS OF A COMPLAINT RECEIVED FROM AN END USER REGARDING A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 24CM DURAMAX KIT. THE CUSTOMER REPORTS THE DEVICE WAS LEAKING. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR RETURN ( WAS REMOVED). NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168366 ↗
• MalfunctionMar 18, 2024Material Integrity Problem; Separation Problem; Material Integrity Problem; Separation Problem

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING TWO (2) BIOFLO DURAMAX 15.5F 24CM DUAL VALVE SHEATH BASIC KITS. THE PEELAWAY INTRODUCER, ONCE INTRODUCED INTO THE VEIN, DID NOT PEEL UNIFORMLY AS ONE WOULD EXPECT, BUT RATHER PARTIALLY PEELED AND BROKE WITHOUT BEING ABLE TO PEEL THE SHEATH TO SUCCESSFULLY IMPLANT THE CATHETER. ANOTHER OF THE SAME DEVICE WAS OPENED, AND THE SAME THING OCCURRED. DUE TO THE SECOND DEVICE FAILURE, THE PATIENT SUFFERED SERIOUS BLEEDING FROM THE RIGHT JUGULAR VEIN. IT WAS ESTIMATED THE PATIENT LOST BETWEEN 600-800ML OF BLOOD AND REQUIRED TWO UNITS OF BLOOD TO BE TRANSFUSED. AFTER THE BLEEDING WAS CONTROLLED, THE CATHETER PLACEMENT PROCEDURE WAS COMPLETED WITH A THIRD DEVICE FROM A COMPETITOR BRAND. THE PATIENT REQUIRED SEVERAL DAYS OF HOSPITALIZATION AND IS REPORTED TO BE RECOVERING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18920662 ↗
• MalfunctionDec 27, 2023Material Puncture/Hole; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A DIALYSIS CATHETER FROM A BIOFLO DURAMAX 15.5F 24CM DUAL VALVE SHEATH BASIC KIT. ON INITIATION OF DIALYSIS, THE NURSE NOTICED AN AIR BUBBLE COMING IN TO THE SYRINGE WHILE ASPIRATING BLOOD FROM ARTERIAL LUMEN OF CVC. UPON CLOSER INSPECTION, A SMALL AMOUNT OF BLOOD WAS LEAKING FROM THE SIDE OF CLEAR RUBBER PART OF ARTERIAL LUMEN OF CVC.THE CATHETER WAS REMOVED AND REPLACED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400671 ↗
• MalfunctionNov 8, 2023Material Puncture/Hole; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO DURAMAX 15.5F 24CM DUAL VALVE SHEATH BASIC KIT. THE DISTRIBUTOR REPORTED THE CATHETER HAD BEEN PLACED IN THE PATIENT'S RIGHT INTERNAL JUGULAR PERMACATH IN (B)(6) 2020. ON (B)(6) 2023, IT WAS REPORTED THAT AN INCIDENT OF A HOLE WAS NOTICED ON THE PERMACATH (AT THE JUNCTION WHERE THE 2 LUMEN MEET) WHILE FLUSHING THE LUMEN. THE PRODUCT HAD BEEN USED IN LINE WITH RECOMMENDATIONS. NO EXTERNAL CLAMPS WERE USED PRIOR TO INCIDENT. THE PATIENT REQUIRED A PERMACATH EXCHANGE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091644 ↗
• MalfunctionApr 3, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A PATIENT'S DURAMAX BIOFLO DIALYSIS CATHETER NEEDED REMOVAL AND REPLACEMENT OF THE CATHETER, DUE TO FLATTENING OF THE TUBE NEAR THE HUB, AND BECOMING FRAGILE PAUSING RISK OF RUPTURE AND BLEEDING/AIR EMBOLISM. IN ADDITION, THERE WAS LEAKAGE FROM THE JUNCTION OF THE HUB WITH THE CLEAR TUBE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662524 ↗
• MalfunctionOct 20, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 24CM DUAL VALVE SHEATH BASIC KIT. POST PROCEDURE, THE ARTERIAL EXTENSION LEG WAS DISCOVERED TO BE LEAKING AT THE JUNCTION POINT OF THE EXTENSION TUBE AND THE LUER. THE LEAK WAS NOTED ON (B)(6) 2021, AFTER 254 DIALYSIS SESSIONS, AND WAS REPAIRED USING LOCTITE GLUE (CYANOACRYLATE). DURING INDWELL OF THE DEVICE, IT WAS REPORTED THE DEVICE WAS CLEANED WITH TAUROLOC AND HEPARIN FOR THE SEAL, AND WERE ALLOWED TO FULLY DRY. IT WAS REPORTED NO SHARP INSTRUMENTS OR SCISSORS WERE USED NEAR THE TUBING, AND WHEN CLAMPED, THE FULL LENGTH OF TUBING WAS USED AT A DIFFERENT LOCATION EACH TIME. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE DEVICE WAS EVENTUALLY REMOVED AND REPLACED WITH A COMPETITOR'S DEVICE. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12663822 ↗
• MalfunctionOct 20, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 24CM DUAL VALVE SHEATH BASIC KIT. POST PROCEDURE, THE ARTERIAL EXTENSION LEG WAS DISCOVERED TO BE LEAKING AT THE JUNCTION POINT OF THE EXTENSION TUBE AND THE LUER. THE SECOND LEAK WAS THEN NOTED ON (B)(6) 2021 AFTER 355 DIALYSIS SESSIONS. AFTER THIS LEAK OCCURRED, THE DECISION WAS MADE TO REMOVE THE DEVICE AND REPLACE WITH A COMPETITOR'S WHICH ALLOWS REPLACING OF THE EXTENSION LEGS. DURING INDWELL OF THE DEVICE, IT WAS REPORTED THE DEVICE WAS CLEANED WITH TAUROLOC AND HEPARIN FOR THE SEAL, AND WERE ALLOWED TO FULLY DRY. IT WAS REPORTED NO SHARP INSTRUMENTS OR SCISSORS WERE USED NEAR THE TUBING, AND WHEN CLAMPED, THE FULL LENGTH OF TUBING WAS USED AT A DIFFERENT LOCATION EACH TIME. THE DEVICE WAS EVENTUALLY REMOVED AND REPLACED WITH A COMPETITOR'S DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12663821 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  PATIENT 1 OF 4: A DISTRIBUTOR REPORTED AN ISSUE WITH BIOFLO CHRONIC DIALYSIS CATHETERS IN FOUR DIFFERENT PATIENTS. DURING DIALYSIS TREATMENTS, AFTER THE CATHETERS WERE CONNECTED TO THE DIALYSIS MACHINES, LEAKAGE WAS NOTED BETWEEN "THE JUNCTION OF THE WHITE PIECE (WHERE LUER LOCK HUB IS) AND THE TRANSPARENT TUBE { EXTENSION LEG} " THE LEAKS OCCURRED ON BOTH THE ARTERIAL AND VENOUS ARMS, IN 4 CATHETERS, 4 DIFFERENT PATIENTS, ALL OF DIFFERENT LOT NUMBERS. IT WAS ALSO REPORTED THAT THE LEAKS COULD OCCUR IN ANY DIALYSIS SESSION, NOT NECESSARILY THE FIRST SESSION AFTER PLACEMENT. AT ALL TIMES, THE USE MADE OF THE CATHETER WAS CORRECT AND IT WAS NOT FORCED OR USED FOR A PURPOSE OTHER THAN THAT INDICATED BY THE MANUFACTURER. THEY HAVE NOT KEPT THE CATHETERS, DUE TO THE URGENCY, THEY ONLY CHANGED THE CATHETERS BUT THEY DID NOT KEEP THEM. PATIENT SAFETY RISK DUE TO THE AIR IN THE SYSTEM AND THE HIGH RISK OF EMBOLISM. THE CATHETERS WERE REMOVED AND REPLACED AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648318 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  PATIENT 3 OF 4: A DISTRIBUTOR REPORTED AN ISSUE WITH BIOFLO CHRONIC DIALYSIS CATHETERS IN FOUR DIFFERENT PATIENTS. DURING DIALYSIS TREATMENTS, AFTER THE CATHETERS WERE CONNECTED TO THE DIALYSIS MACHINES, LEAKAGE WAS NOTED BETWEEN "THE JUNCTION OF THE WHITE PIECE (WHERE LEUR LOCK HUB IS) AND THE TRANSPARENT TUBE { EXTENSION LEG} " THE LEAKS OCCURRED ON BOTH THE ARTERIAL AND VENOUS ARMS, IN 4 CATHETERS, 4 DIFFERENT PATIENTS, ALL OF DIFFERENT LOT NUMBERS. IT WAS ALSO REPORTED THAT THE LEAKS COULD OCCUR IN ANY DIALYSIS SESSION, NOT NECESSARILY THE FIRST SESSION AFTER PLACEMENT. AT ALL TIMES, THE USE MADE OF THE CATHETER WAS CORRECT AND IT WAS NOT FORCED OR USED FOR A PURPOSE OTHER THAN THAT INDICATED BY THE MANUFACTURER. THEY HAVE NOT KEPT THE CATHETERS, DUE TO THE URGENCY, THEY ONLY CHANGED THE CATHETERS BUT THEY DID NOT KEEP THEM. PATIENT SAFETY RISK DUE TO THE AIR IN THE SYSTEM AND THE HIGH RISK OF EMBOLISM. THE CATHETERS WERE REMOVED AND REPLACED AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648315 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  PATIENT 2 OF 4: A DISTRIBUTOR REPORTED AN ISSUE WITH BIOFLO CHRONIC DIALYSIS CATHETERS IN FOUR DIFFERENT PATIENTS. DURING DIALYSIS TREATMENTS, AFTER THE CATHETERS WERE CONNECTED TO THE DIALYSIS MACHINES, LEAKAGE WAS NOTED BETWEEN "THE JUNCTION OF THE WHITE PIECE (WHERE LEUR LOCK HUB IS) AND THE TRANSPARENT TUBE { EXTENSION LEG} " THE LEAKS OCCURRED ON BOTH THE ARTERIAL AND VENOUS ARMS, IN 4 CATHETERS, 4 DIFFERENT PATIENTS, ALL OF DIFFERENT LOT NUMBERS. IT WAS ALSO REPORTED THAT THE LEAKS COULD OCCUR IN ANY DIALYSIS SESSION, NOT NECESSARILY THE FIRST SESSION AFTER PLACEMENT. AT ALL TIMES, THE USE MADE OF THE CATHETER WAS CORRECT AND IT WAS NOT FORCED OR USED FOR A PURPOSE OTHER THAN THAT INDICATED BY THE MANUFACTURER. THEY HAVE NOT KEPT THE CATHETERS, DUE TO THE URGENCY, THEY ONLY CHANGED THE CATHETERS BUT THEY DID NOT KEEP THEM. PATIENT SAFETY RISK DUE TO THE AIR IN THE SYSTEM AND THE HIGH RISK OF EMBOLISM. THE CATHETERS WERE REMOVED AND REPLACED AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648314 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  PATIENT 4 OF 4: A DISTRIBUTOR REPORTED AN ISSUE WITH BIOFLO CHRONIC DIALYSIS CATHETERS IN FOUR DIFFERENT PATIENTS. DURING DIALYSIS TREATMENTS, AFTER THE CATHETERS WERE CONNECTED TO THE DIALYSIS MACHINES, LEAKAGE WAS NOTED BETWEEN "THE JUNCTION OF THE WHITE PIECE (WHERE LEUR LOCK HUB IS) AND THE TRANSPARENT TUBE { EXTENSION LEG} " THE LEAKS OCCURRED ON BOTH THE ARTERIAL AND VENOUS ARMS, IN 4 CATHETERS, 4 DIFFERENT PATIENTS, ALL OF DIFFERENT LOT NUMBERS. IT WAS ALSO REPORTED THAT THE LEAKS COULD OCCUR IN ANY DIALYSIS SESSION, NOT NECESSARILY THE FIRST SESSION AFTER PLACEMENT. AT ALL TIMES, THE USE MADE OF THE CATHETER WAS CORRECT AND IT WAS NOT FORCED OR USED FOR A PURPOSE OTHER THAN THAT INDICATED BY THE MANUFACTURER. THEY HAVE NOT KEPT THE CATHETERS, DUE TO THE URGENCY, THEY ONLY CHANGED THE CATHETERS BUT THEY DID NOT KEEP THEM. PATIENT SAFETY RISK DUE TO THE AIR IN THE SYSTEM AND THE HIGH RISK OF EMBOLISM. THE CATHETERS WERE REMOVED AND REPLACED AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648313 ↗
• MalfunctionDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER. DURING A PROCEDURE, THE TUNNELER WAS COMING UNATTACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024708 ↗
• MalfunctionDec 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER RISK MANAGER REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 24CM DUAL VALVE SHEATH BASIC KIT. THE TUNNELED DIALYSIS CATHETER SLEEVE BECAME STUCK ON THE CATHETER WHEN THE PHYSICIAN PULLED IT THROUGH THE TUNNELED TRACK, CAUSING THE SLEEVE TO BREAK OFF INSIDE OF THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PIECE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983756 ↗
• MalfunctionNov 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AND ISSUE WITH BIOFLO DIALYSIS CATHETERS. IT WAS REPORTED THAT THE PHYSICIANS "HAVE NOTICED THAT THE TUNNELER IS COMING UNATTACHED FROM THE CATHETER DURING PROCEDURES. THERE WAS NO REPORT OF PATIENT HARM BY THE END USER. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828051 ↗
• MalfunctionMar 9, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED: THE EVENT OCCURRED IN THE DIALYSIS ROOM, WHEN THE NURSE CONNECTED THE CATHETER TO THE DIALYSIS MACHINE, WAS A LEAK BETWEEN THE JUNCTION THE WHITE PIECE (WHERE IS THE LUER LOCK (HUB?) I DON´T KNOW IF IS THE ARTERIAL OR VENOUS ARM) WITH THE TRANSPARENT TUBE. [EXTENSION LEG, DETACHED/SEPARATED/FRACTURED] IT WAS REPORTED THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9805812 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  4TH INCIDENT: IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHERS THAT WERE NOTED TO BE LEAKING BETWEEN TH JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794523 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  3RD INCIDENT: IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHETERS THAT WERE NOTED TO BE LEAKING BETWEEN THE JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794287 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  9TH INCIDENT. IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHETERS THAT WERE NOTED TO BE LEAKING BETWEEN TH JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794281 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  8TH INCIDENT. IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHERS THAT WERE NOTED TO BE LEAKING BETWEEN TH JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794280 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  1ST INCIDENT. IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHERS THAT WERE NOTED TO BE LEAKING BETWEEN TH JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794277 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  5TH INCIDENT: IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHERS THAT WERE NOTED TO BE LEAKING BETWEEN TH JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794276 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  2ND INCIDENT: IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHETERS THAT WERE NOTED TO BE LEAKING BETWEEN THE JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794274 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  6TH INCIDENT: IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHERS THAT WERE NOTED TO BE LEAKING BETWEEN TH JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794272 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  7TH INCIDENT. IT WAS REPORTED THAT THERE WERE 9 OCCURRENCES OF BIOFLO DIALYSIS CATHERS THAT WERE NOTED TO BE LEAKING BETWEEN TH JUNCTION OF THE HUB AND TUBING (EXTENSION LEG). IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794266 ↗