Bard® Blakemore Esophageal-Nasogastric Tube 0092100Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741076800), received between Apr 26, 2017 and May 22, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Apr 17, 2025Class IOpen, Classified

   Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

   Z-1756-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Material Rupture

  IT WAS REPORTED THAT THE INTUBATED WITH BLAKEMORE IN SITU. COUGHING WENT TO SUCTION ETT AND BLAKEMORE TUBE CAME OUT. GASTRIC BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263015 ↗
• InjuryDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT 12:15 AM WITH 250 ML OF AIR BY THE DR. AT 3:44PM. PATIENT WAS FOUND TO BE BLEEDING FROM THE MOUTH. THE CATHETER RIPPED INSIDE THE PATIENT. CUSTOMER ADVISED THEY WOULD BE SENDING EMAIL WITH MORE DETAILS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23778984 ↗
• MalfunctionDec 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PATIENT HAD BLAKEMORE PLACED AT 0152 INSIDE OF PATIENT WITH 250ML OF AIR INSERTED INTO FATRIC PORT BY A PHYSICIAN. AT 0344, PATIENT WAS FOUND BLEEDING FROM MOUTH, AND IT WAS FOUND BY PHYSICIANS THAT THE GASTRIC PART OF THE BLAKEMORE WAS RIPPED WHILE IN THE PATIENT. A NEW BLAKEMORE WAS PLACED, AND PATIENT WAS TRANSPORTED DEFECTIVE BLAKEMORE WAS PLACED AND PATIENT WAS TRANSPORTED DEFECTIVE BLAKEMORE WAS GIVEN TO STERILE PROCESSING. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER RESPONSE RECEIVED ON 22DEC2025, NO PATIENT HARM WAS NOTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23771029 ↗
• MalfunctionSep 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY DID NOT INFLATE THE BLAKEMORE TUBE COMPLETELY. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL RESPONSE ON 02DEC2025. IT WAS REPORTED THAT THE PRODUCT WAS RETURNED ON 29SEP2025 AND SHOULD BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23132991 ↗
• MalfunctionSep 22, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT BLAKEMORE TUBE DID NOT INFLATE COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109794 ↗
• InjuryAug 15, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT WAS ADMITTED WITH ESPHAGEAL VARICES. BLAKEMORE TUBE BALLOON CHECKED. BLAKEMORE TUBE INSERTED ACCORDING TO UNIT POLICY/PROCEDURE. ONCE PLACED THE DEVICE WAS CONFIRMED BY X-RAY. THE BALLOON WAS INFLATED ACCORDING TO THE POLICY/PROCEDURE AND BLEEDING STOPPED. WHEN TRACTION WAS APPLIED THE DEVICE SLID OUT AND NOTED THAT THE BALLOON WAS COMPLETELY DEFLATED. THE PATIENT BEGAN BLEEDING A VERY LARGE AMOUNT AGAIN AND A NEW BLAKEMORE TUBE HAD TO BE PLACED. NO FURTHER ADVERSE PATIENT IMPACT. MEDICAL INTERVENTION IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22816289 ↗
• MalfunctionJun 25, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THEY HAVE 5 OF ITEM # 0092100 AND RECEIVED A NOTICE THAT ALL LOTS WITHIN EXPIRATION DATE HAVE BEEN RECALLED. THEIR ED DEPARTMENT WAS HAVING A HARD TIME PULLING THE PLASTIC PLUG AND DON'T WANT TO COMPROMISE THE PRODUCT BY STRETCHING IT OUT TOO MUCH. HAS THERE BEEN NEW PRODUCTION ON THIS ITEM THAT CAN REPLACE THE BAD ONES THEY HAVE? IF NOT, WAS THERE A SUB THAT CAN BE USED IN ITS PLACE? USERS WERE ADVISED TO STORE STRAIGHT SMOOTH JAW HEMOSTAT WITH THE AFFECTED DEVICES FOR IMMEDIATE AVAILABILITY TO BE USED FOR PLASTIC PLUG REMOVAL. USERS WERE ADVISED TO MAINTAIN AVAILABLE SECONDARY BALLOON TAMPONADE DEVICES FOR IMMEDIATE REPLACEMENT IF THE PRIMARY DEVICE WAS DAMAGED DURING PLASTIC PLUG REMOVAL. USERS CAN CONTINUE TO USE THE DEVICES AND SHOULD REVIEW AND FOLLOW THE INSTRUCTIONS FOR REMOVAL OF THE PLASTIC PLUGS PROVIDED IN THIS MEDICAL DEVICE CORRECTION LETTER TO AVOID POTENTIAL HEALTH CONSEQUENCES IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330512 ↗
• MalfunctionMar 20, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER USING A BLAKEMORE TUBE IN A SIMULATION AND WERE TRYING TO SET IT UP, HAD GREAT DIFFICULTY REMOVING THE WHITE PLASTIC PLUGS THAT WERE PRESENT IN BOTH THE ESOPHAGEAL AND GASTRIC TUBES. THIS WAS THE SECOND TIME THIS HAS OCCURRED WHEN STAFF WERE TRYING TO SET UP THE BLAKEMORE FOR TEACHING PURPOSES. IT TOOK SEVERAL MINUTES AS WELL AS HAVING TO USED DIFFERENT CLAMPS TO TRY TO REMOVE THEM. THE STAFF WERE CONCERNED ABOUT CRACKING OR DAMAGING THE TUBING WITH ALL THE DIFFERENT WAYS, HAD TO USE THE CLAMPS TO DISLODGE THE PLUGS. THE STAFF HAD A SECOND INCIDENT LATER OVERNIGHT WITH AN ACTUAL PATIENT THAT REQUIRED A BLAKEMORE BE INSERTED AND THE NURSES PRESENT DID ALSO STRUGGLE TO GET THE PLUGS REMOVED. THE TIME REQUIRED TO TRY TO REMOVE THE PLUGS DURING A CRITICAL EVENT SUCH AS A GI BLEED WAS NOT IDEAL. NO SERIOUS HARM WAS REPORTED. THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652366 ↗
• MalfunctionMar 20, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CUSTOMER USING A BLAKEMORE TUBE IN A SIMULATION AND WERE TRYING TO SET IT UP, HAD GREAT DIFFICULTY REMOVING THE WHITE PLASTIC PLUGS THAT WERE PRESENT IN BOTH THE ESOPHAGEAL AND GASTRIC TUBES. THIS WAS THE SECOND TIME THIS HAS OCCURRED WHEN STAFF WERE TRYING TO SET UP THE BLAKEMORE FOR TEACHING PURPOSES. IT TOOK SEVERAL MINUTES AS WELL AS HAVING TO USED DIFFERENT CLAMPS TO TRY TO REMOVE THEM. THE STAFF WERE CONCERNED ABOUT CRACKING OR DAMAGING THE TUBING WITH ALL THE DIFFERENT WAYS, HAD TO USE THE CLAMPS TO DISLODGE THE PLUGS. THE STAFF HAD A SECOND INCIDENT LATER OVERNIGHT WITH AN ACTUAL PATIENT THAT REQUIRED A BLAKEMORE BE INSERTED AND THE NURSES PRESENT DID ALSO STRUGGLE TO GET THE PLUGS REMOVED. THE TIME REQUIRED TO TRY TO REMOVE THE PLUGS DURING A CRITICAL EVENT SUCH AS A GI BLEED WAS NOT IDEAL. NO SERIOUS HARM WAS REPORTED. THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652219 ↗
• MalfunctionAug 20, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BLAKEMORE TUBE WOULD NOT STAY INFLATED. THIS OCCURRED TWICE, BOTH WITH A DIFFERENT LOT NUMBER (LOT#MCGS4478 AND LOT#MCHP1209 ). NO ADVERSE EVENT AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007241 ↗
• MalfunctionAug 20, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BLAKEMORE TUBE WOULD NOT STAY INFLATED. THIS OCCURRED TWICE, BOTH WITH A DIFFERENT LOT NUMBER (LOT#MCGS4478 AND LOT#MCHP1209). NO ADVERSE EVENT AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004479 ↗
• MalfunctionMay 20, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE BLAKEMORE TUBE OF WHITE PEGS THAT COME IN THE PORTS WHEN THE PRODUCT WAS NEW USED TO BE EASILY REMOVED WITH FINGERS. NOW THEY WERE STRUGGLING WITH HEMOSTATS TO REMOVE THE PEGS BEFORE USE AS THEY WERE INSERTED SO TIGHTLY, THEY WERE LOOKING FOR ADVICE ON HOW BEST TO REMOVE THESE PRIOR TO USE OF THE NEEDED PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350770 ↗
• MalfunctionApr 12, 2024Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE BLAKEMORE TUBE CAME OUT. STAFF WAS UNABLE TO ASPIRATE THE AIR FROM THE GASTRIC BALLOON. STAFF REMOVED THE BLAKEMORE AND DISCOVERED THAT THE GASTRIC BALLOON WAS RUPTURED. THERE WAS A PROLONGED CARE AND THERE WAS NO INVASIVE PROCEDURE PROVIDED. PER ADDITIONAL INFORMATION RECEIVED ON 27MAR2024, NO BLEEDING AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19095760 ↗
• MalfunctionMar 13, 2024Material Too Rigid or Stiff; Separation Failure; Material Too Rigid or Stiff; Separation Failure

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE HAD A HARD PLASTIC CAP THAT ARE HARD TO GET OUT AND HAVING TO CUT THEM OFF. PER ADDITIONAL INFORMATION RECEIVED ON 23FEB2024, THE WHITE HARD PLASTIC INSERT THAT WAS IN 2 OF THE PORTS WAS NOT ABLE TO BE REMOVED, IN ORDER TO USE THE PRODUCT AND THEY WERE HAVING TO CUT THE TUBING. PER ADDITIONAL INFORMATION RECEIVED ON 26FEB2024, THE WHITE ¿CAPS¿ IN TWO OF THE ENDS OF THE TUBES WERE UNABLE TO BE REMOVED, CAPS WERE SOLID, UNABLE TO USE, HAVE HAD TO CUT TUBING TO USE, THEN TUBE WAS TOO SHORT. IT WAS ALSO STATED THAT ALL THE PRODUCT WAS LIKE THIS AND THERE WAS DELAY IN CARE WITH INSERTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18893257 ↗
• MalfunctionFeb 15, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN TRYING TO INFLATE THE BALLOON OF ESOPHAGEAL TUBE, THE PHYSICIAN NOTIFIED THERE WAS A TEAR IN THE CREASE AT THE BASE OF THE TUBE. PRODUCT WAS NOT ABLE TO BE USED TO THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710544 ↗
• MalfunctionFeb 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN TRYING TO INFLATE THE BALLOON, THE PHYSICIAN NOTIFIED THERE WAS TEAR IN A CREASE AT THE BASE OF THE BLAKEMORE TUBE AND IT WAS NOT ABLE TO BE USED TO THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676164 ↗
• MalfunctionJun 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THREE (3) OF THE BLAKEMORE SPECIALTY TUBES DID NOT INFLATE PRIOR TO BEING INSERTED IN A PATIENT IN THE INTENSIVE CARE UNIT (ICU). IT WAS NOTED THAT THE SPECIALTY TUBES WERE NOT EXPIRED. THE CUSTOMER ADDITIONALLY NOTICED THAT THERE WAS DISCOLORATION WITH THE THREE (3) FAILED TUBES. EACH TUBE WAS A DIFFERENT LOT# AND EXPIRATION DATE. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 12-JUNE-2023, THE CLINICAL EDUCATION SPECIALIST REPORTED THAT THE PATIENT WAS DECEASED. THE PATIENT WAS BEING CODED WHEN THE ENDOSCOPY TEAM ARRIVED TO SET UP THE TUBE, AND THE CODE WAS ANNOUNCED WHILE THE ENDOSCOPY TEAM WAS SETTING UP. THE TEAM HAD THE BLAKEMORE KIT SET UP, AND THEY ATTEMPTED TO TEST THE BALLOONS BEFORE USE. THE BALLOONS FROM BOTH OF THE TUBES IN THE KIT AS WELL AS AN ADDITIONAL TUBE FROM THE ICU WOULD NOT STAY INFLATED. ANOTHER TUBE WAS OBTAINED FROM THE OPERATING ROOM (OR). THERE WAS NO DISCOLORATION NOTED AND THE BALLOONS WERE ABLE TO REMAIN INFLATED. THE CLINICAL EDUCATION SPECIALIST STATED THAT THE ISSUES ENCOUNTERED WITH THE BLAKEMORE TUBES DID NOT DELAY NOR IMPACT THE OUTCOME. PER CLINICAL FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 23-JUNE-2023, THE ENDOSCOPY AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224502 ↗
• MalfunctionJun 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO (2) OF THE BLAKEMORE SPECIALTY TUBES DID NOT INFLATE PRIOR TO BEING INSERTED IN A PATIENT IN THE INTENSIVE CARE UNIT (ICU). IT WAS NOTED THAT THE SPECIALTY TUBES WERE NOT EXPIRED. THE CUSTOMER ADDITIONALLY NOTICED THAT THERE WAS DISCOLORATION WITH THE TWO (2) FAILED TUBES. EACH TUBE WAS A DIFFERENT LOT# AND EXPIRATION DATE. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 12-JUNE-2023, THE CLINICAL EDUCATION SPECIALIST REPORTED THAT THE PATIENT WAS DECEASED. THE PATIENT WAS BEING CODED WHEN THE ENDOSCOPY TEAM ARRIVED TO SET UP THE TUBE, AND THE CODE WAS ANNOUNCED WHILE THE ENDOSCOPY TEAM WAS SETTING UP. THE TEAM HAD THE BLAKEMORE KIT SET UP, AND THEY ATTEMPTED TO TEST THE BALLOONS BEFORE USE. THE BALLOONS IN THE KIT WOULD NOT STAY INFLATED. ANOTHER KIT OBTAINED FROM THE ICU, BUT THE BALLOONS WOULD NOT STAY INFLATED. IT WAS ALSO NOTED THAT BOTH OF THESE FAILED DEVICES WERE DISCOLORED. AN ADDITIONAL TUBE WAS OBTAINED FROM THE OPERATING ROOM (OR). THERE WAS NO DISCOLORATION NOTED AND THE BALLOONS WERE ABLE TO REMAIN INFLATED. THE CLINICAL EDUCATION SPECIALIST STATED THAT THE ISSUES ENCOUNTERED WITH THE BLAKEMORE TUBES DID NOT DELAY NOR IMPACT THE OUTCOME. PER C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224169 ↗
• MalfunctionDec 22, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE USER COULD NOT REMOVE PLUGS FROM BLAKEMORE TUBE. THIS DELAYED THE PATIENT CARE. THE DEVICE WAS UNFIT FOR USE AFTER CLINICIANS USED INSTRUMENTS TO TRY TO REMOVE THE PLUGS AND ENDED UP DAMAGING THE TUBE. AS PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 15-DEC-2022, STATED THAT THE PATIENT WAS NOT INJURED BUT THE CARE REQUIRING THE BLAKEMORE TUBE WAS DELAYED. IT TOOK SEVERAL PEOPLE TO TRY AND REMOVE THE PLUGS AND THEY HAD TO RESORT IN OPENING ANOTHER BLAKEMORE TUBE THINKING IT WAS DEFECTIVE. IT WAS CRITICAL SITUATION THAT THE PATIENT WAS BLEEDING PROFUSELY AND THE DELAY CAUSED UNNECESSARY BLEEDING THAT COULD HAVE BEEN STOPPED IF THE BLAKEMORE TUBE WAS IN PLACE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16033673 ↗
• InjuryDec 22, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE USER COULD NOT REMOVE PLUGS FROM BLAKEMORE TUBE. THIS DELAYED THE PATIENT CARE. THE DEVICE WAS UNFIT FOR USE AFTER CLINICIANS USED INSTRUMENTS TO TRY TO REMOVE THE PLUGS AND ENDED UP DAMAGING THE TUBE. AS PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 15-DEC-2022, STATED THAT THE PATIENT WAS NOT INJURED BUT THE CARE REQUIRING THE BLAKEMORE TUBE WAS DELAYED. IT TOOK SEVERAL PEOPLE TO TRY AND REMOVE THE PLUGS AND THEY HAD TO RESORT IN OPENING ANOTHER BLAKEMORE TUBE THINKING IT WAS DEFECTIVE. IT WAS CRITICAL SITUATION THAT THE PATIENT WAS BLEEDING PROFUSELY AND THE DELAY CAUSED UNNECESSARY BLEEDING THAT COULD HAVE BEEN STOPPED IF THE BLAKEMORE TUBE WAS IN PLACE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16033669 ↗
• MalfunctionOct 20, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH NASOGASTRIC TUBES AND HAD A PROBLEM WITH GASTRIC BALLOONS THAT DID NOT INFLATE AND DEFLATE APPROPRIATELY. IT HAPPENED TWICE DURING A MEDICAL EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638893 ↗
• MalfunctionSep 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BLAKEMORE TUBE WAS DAMAGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425565 ↗
• MalfunctionApr 21, 2020Dent in Material; Inflation Problem; Dent in Material

  IT WAS REPORTED THAT DURING INFLATION OF THE GASTRIC BALLOON, A "DIMPLE" WAS OBSERVED IN ONE SIDE OF THE BALLOON. THE USER INITIALLY INFLATED THE BALLOON WITH 50-60CC OF FLUID AND THEN OVER-INFLATED WITH 100CC AND TOUCHED THE BALLOON IN ORDER RELEASE THE "DIMPLE OUT". THE BALLOON WAS THEN DEFLATED ONCE THE "DIMPLE" WAS RELEASED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9981775 ↗
• MalfunctionMar 3, 2020Difficult to Remove; Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CUSTOMER STATED WHEN THEY HAD TO USE THEM, IT IS PARTICULARLY DIFFICULT TO REMOVE THE 2 PLASTIC CAPS ON THE END OF THE TUBE. THEY HAD TO USE LARGE KELLY CLAMPS & HAVE STILL FOUND IT DIFFICULT TO REMOVE THEM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9782227 ↗
• MalfunctionNov 20, 2019Burst Container or Vessel; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED WHILE IN A PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9349981 ↗