BD Bonnano 408289Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382904082895), received between Aug 1, 2019 and Oct 16, 2023 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS MDR 3 OF 3 (PATIENT 2). CUSTOMER ADVISED THAT BLADDER PERFORATIONS HAD OCCURRED WITH 3 PATIENTS FOLLOWING INSERTION OF BONANNO SUPRAPUBIC CATHETERS. THESE INCIDENTS ARE GOING TO BE INVESTIGATED BY THE HOSPITAL TO TRY TO IDENTIFY IF THIS IS PRODUCT OR USER RELATED. NO LOT NUMBERS OR SAMPLES ARE AVAILABLE, ALTHOUGH THESE WILL BE TRACKED FOR FUTURE PATIENTS. 3X PATIENTS WITH BLADDER PERFORATIONS.1 PATIENT ALSO SUFFERED A CARDIAC ARREST. ADDITIONAL INFORMATION: 11-OCT-2023 - RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION REQUESTED. ANSWERS ADDED IN FOLLOW UP TAB. REFER EMAIL ATTACHED. 1. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) PATIENT 1: YES - BLADDER INJURY, HAEMATURIA, UNPLANNED RETURN TO THEATRE (LAPAROTOMY POST CARDIAC ARREST), ICU ADMISSION, EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 17DAYS), LATER RE-ADMISSION FOR CYSTOSCOPY PATIENT 2: YES ¿ BLADDER PERFORATION ON CT, ABDO PAIN, EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 13 DAYS) PATIENT 3: YES ¿ BLADDER INJURY, HAEMATURIA, UNPLANNED RETURN TO THEATRE (CYSTOSCOPY), EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 8 DAYS) 2. DID THREE PATIENTS EXPERIENCE BLADDER PERFORATION AND ONE OF THOSE PATIENTS EXPERIENCES

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 17938912 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS MDR 1 OF 3 (PATIENT 1) CUSTOMER ADVISED THAT BLADDER PERFORATIONS HAD OCCURRED WITH 3 PATIENTS FOLLOWING INSERTION OF BONANNO SUPRAPUBIC CATHETERS. THESE INCIDENTS ARE GOING TO BE INVESTIGATED BY THE HOSPITAL TO TRY TO IDENTIFY IF THIS IS PRODUCT OR USER RELATED. NO LOT NUMBERS OR SAMPLES ARE AVAILABLE, ALTHOUGH THESE WILL BE TRACKED FOR FUTURE PATIENTS. 3X PATIENTS WITH BLADDER PERFORATIONS. 1 PATIENT ALSO SUFFERED A CARDIAC ARREST. ADDITIONAL INFORMATION: 11-OCT-2023 - RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION REQUESTED. ANSWERS ADDED IN FOLLOW UP TAB. REFER EMAIL ATTACHED. 1. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL). PATIENT 1: YES - BLADDER INJURY, HAEMATURIA, UNPLANNED RETURN TO THEATRE (LAPAROTOMY POST CARDIAC ARREST), ICU ADMISSION, EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 17DAYS), LATER RE-ADMISSION FOR CYSTOSCOPY. PATIENT 2: YES ¿ BLADDER PERFORATION ON CT, ABDO PAIN, EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 13 DAYS). PATIENT 3: YES ¿ BLADDER INJURY, HAEMATURIA, UNPLANNED RETURN TO THEATRE (CYSTOSCOPY), EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 8 DAYS). 2. DID THREE PATIENTS EXPERIENCE BLADDER PERFORATION AND ONE OF THOSE PATIENTS EXPERIE

  Patient problems: Cardiac Arrest; Hematuria; Perforation

  MAUDE report 17938908 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS MDR 2 OF 3 (PATIENT 3) CUSTOMER ADVISED THAT BLADDER PERFORATIONS HAD OCCURRED WITH 3 PATIENTS FOLLOWING INSERTION OF BONANNO SUPRAPUBIC CATHETERS. THESE INCIDENTS ARE GOING TO BE INVESTIGATED BY THE HOSPITAL TO TRY TO IDENTIFY IF THIS IS PRODUCT OR USER RELATED. NO LOT NUMBERS OR SAMPLES ARE AVAILABLE, ALTHOUGH THESE WILL BE TRACKED FOR FUTURE PATIENTS. 3X PATIENTS WITH BLADDER PERFORATIONS.1 PATIENT ALSO SUFFERED A CARDIAC ARREST. ADDITIONAL INFORMATION: 11-OCT-2023 - RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION REQUESTED. ANSWERS ADDED IN FOLLOW UP TAB. REFER EMAIL ATTACHED. 1. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) PATIENT 1: YES - BLADDER INJURY, HAEMATURIA, UNPLANNED RETURN TO THEATRE (LAPAROTOMY POST CARDIAC ARREST), ICU ADMISSION, EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 17DAYS), LATER RE-ADMISSION FOR CYSTOSCOPY PATIENT 2: YES ¿ BLADDER PERFORATION ON CT, ABDO PAIN, EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 13 DAYS) PATIENT 3: YES ¿ BLADDER INJURY, HAEMATURIA, UNPLANNED RETURN TO THEATRE (CYSTOSCOPY), EXTENDED LENGTH OF STAY (FROM 4 DAYS TO 8 DAYS) 2. DID THREE PATIENTS EXPERIENCE BLADDER PERFORATION AND ONE OF THOSE PATIENTS EXPERIENCES

  Patient problems: Hematuria

  MAUDE report 17938906 ↗
• MalfunctionJul 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT 3 BD BONNANO¿ CATHETER TRAYS EXPERIENCED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER DOES NOT GLIDE OVER THE NEEDLE ON INSERTION OF THE DRAIN. INSTEAD, A LARGE AMOUNT OF FORCE IS REQUIRED TO INITIATE THE 'SLIDE' OF THE CATHETER, THEN A SUDDEN LOSS OF RESISTANCE (PRESUMABLY AS THE OVERLY TIGHT TIP OF THE CATHETER IS NO LONG SQUEEZING ON THE NEEDLE) THIS RESULTS IN A 'JOLT'. IT APPEARS THE CATHETER IS TOO TIGHT AROUND THE TIP OF THE NEEDLE. INDEED THIS COULD BE FELT WHEN ASSEMBLING TO APPARATUS. MY FEAR IS THAT THIS COULD RESULT IN A FAILURE - IF THE PRACTITIONER ACCIDENTLY WITHDRAWS THE NEEDLE THEY ARE PULLING ON, THEY MAY THEN BE UNABLE TO SAFELY ADVANCE THE CATHETER. OR WORSE, IF THERE IS THEN A COMPENSATORY FORWARD MOTION THEN THE NEEDLE COULD BE PUSHED FURTHER INTO THE ABDOMEN THAN DESIRED..... I HAPPENED TO SIT OPPOSITE SOME OF THE GASTRO ENTEROLOGY TEAM AT LUNCH TODAY. 3 OF THE 4 HAD EXPERIENCED THIS ISSUE ON AT LEAST 1 DRAIN IN THE LAST 2 WEEKS. 2 OF THE 3, FELT THE FAULT WHILST ASSEMBLING THE NEEDLE/CATHETER UNIT AND SWAPPED FOR ANOTHER. NONE OF THEM RECORDED LOT NUMBERS. IN THE FIRST CASE CHRONOLOGICALLY I SWAPPED OUT AN

  Patient problems: Hematoma

  MAUDE report 15089867 ↗
• MalfunctionJun 27, 2022Break; Break

  IT WAS REPORTED THAT 2 BD BONNANO¿ CATHETER TRAY CATHETERS WAS FOUND DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 X BONANNO CATHETERS FOUND FAULTY BY DR (B)(6) UPON ATTEMPING TO INSERT ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828869 ↗
• MalfunctionNov 19, 2021Defective Device; Defective Device

  IT WAS REPORTED BD BONNANO¿ CATHETER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE DR WAS PREPARING AND TESTING CATHETER AS ROUTINE PRIOR TO INSERTION AND NOTICED AN ABNORMAL RESISTANCE WHEN SLIDING NEEDLE OVER CATHETER COMPARED TO THE USUAL FEEL WITH THESE DEVICES. HE FELT IT WAS NOT APPROPRIATE TO PROCEED AND USED ANOTHER DEVICE WITHOUT THIS ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849310 ↗
• MalfunctionSep 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED WHEN USING THE TRAY BONANNO CATHETER S/SU, THE DEVICE EXPERIENCED THE CATHETER BREAKING APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PLASTIC SHEATH AROUND THE NEEDLE SEEMS TO BE TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450355 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT TRAY BONANNO CATHETER S/SU CATHETER BROKE APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REASON FOR COMPLAINT: THE METAL INSIDE (NEEDLE) OF THE CATHETER WAS VERY STIFF TO RE INSERT BACK INTO THE CATHETER PRIOR TO BEING INSERTED. THEN WHEN THE NEEDLE PUSHED BACK INTO CATHETER THE END 3 OR 4 CMS OF THE CATHETER CAME OFF.

  MAUDE report 11388571 ↗
• InjuryFeb 4, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER REMOVAL OF DRAIN PART OF IT REMAINED INSIDE PATIENT WITH A BD TRAY BONANNO CATHETER S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT WAS ADMITTED WITH CIRRHOSIS AND ASCITES. (B)(6) 2020 TRIAL FOR ASCETIC DRAIN INSERTION ATTEMPTED WITH NO SUCCESS. NEXT MONDAY (B)(6) 2020 DRAIN INSERTED AFTER US MARKING OF THE LOCATION. DRAIN INSERTED AT 1730, BY ME WITH SPR PRESENCE, WITH SOME DIFFICULTY DUE TO PATIENT BODY HABITUS, BUT NO OBVIOUS CONCERNS. NIGHT STAFF DID NOT REMOVE DRAIN UNTIL THE NEXT DAY, HOWEVER, IT WAS CLAMPED. THE DRAIN WAS REMOVED BY ME THE NEXT DAY. HOWEVER, PART OF IT WAS MISSING (NEARLY 10 CM). I AM UNSURE WHAT MIGHT HAVE CAUSED THIS. QGM (RP): ALERTED TO THE INCIDENT BY WARD MANAGER, FOR WHICH TWO ISSUES CAME TO MIND IMMEDIATELY; I) POTENTIAL NEVER EVENT AS IS A RETAINED FOREIGN BODY, AND II) AN (B)(6) NOTIFIABLE INCIDENT, DUE TO THE DRAIN POTENTIALLY BEING PART OF A FAULTY BATCH. IN RELATION TO THE TWO POINTS ABOVE: DISCUSSED THE INCIDENT WITH THE PATIENT SAFETY LEAD AND ASSOCIATE DIRECTOR OF QUALITY GOVERNANCE. REVIEW OF THE NEVER EVENTS LIST CONFIRMED THIS IS NOT A NEVER EVENT, DUE TO THE SECOND BULLET POINT OF

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9666330 ↗
• MalfunctionAug 1, 2019Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT A BROKEN CATHETER OCCURRED DURING USE WITH A TRAY BONANNO CATHETER S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CNM INFORMED ME THAT A SENIOR REGISTER WAS DOING AN ABDOMINAL TAP TO REMOVE FLUID FROM PATIENT ABDOMINAL WHEN THE CATHETER KINKED. TRIED 2ND CATHETER AND TIP BROKE OFF. ALL OFF DEVICE RETRIEVED FROM PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 8853041 ↗