BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BONNANO¿ SUPRAPUBIC CATHETER TRAY

    MDR report key: 5578700 · Received April 14, 2016

    Report

    Report Number
    2618282-2016-00003
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    March 12, 2016
    Report Date
    August 19, 2016
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FEZ
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. AN EVALUATION OF PHOTOS SENT BY THE PATIENT CONFIRMED THE INDICATED FAILURE AS THEY SHOWED THE ISSUES THAT WERE RAISED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT # WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: THE INVESTIGATION SUMMARY CONDUCTED BY OUR QUALITY ENGINEER STATES THE FOLLOWING: THE PHOTOS ARE OF CATALOG 408289 BONANNO SUBRAPUBIC BLADDER DRAINAGE CATHETER. THE CATHETER IS RECEIVED AS A RAW MATERIAL FROM (B)(4). ELONGATION TESTING IS PERFORMED AS PART OF INCOMING INSPECTION ON AN INSTRON. THE MATERIAL IS SO STRONG THAT IT WILL JUST STRETCH AND THIN OUT BEFORE BREAKING. PULL TESTING IS ALSO PERFORMED DURING ASSEMBLY PROCESS AFTER HUB TO CATHETER ASSEMBLY. THE SAME THINNING OUT CONDITION ON THE CATHETER IS SEEN. THE QUALITY OF THE PHOTOS DO NOT LET US DETERMINE THE CONDITION OF THE CATHETER WHERE THE BREAKAGE OCCURS. FROM THE PHOTOS WE CAN SEE A BEND (WHICH COULD HAVE BEEN CAUSED DURING REMOVAL), THE BREAKAGE POINT AND IN SOME AREAS THE CATHETER LOOKS FLATTENED. A CLEARER PHOTO OF THE CATHETER ENDS THAT BROKE MAY HELP TO DETERMINE IF THE CUT IS MADE BY A SHARP OBJECT. IT IS IMPORTANT TO NOTE THAT IF THE CATHETER WAS INSERTED INTO THE PATIENT, THE CATHETER COULD NOT HAVE BEEN PREVIOUSLY DAMAGED. TO INSERT THE CATHETER, THE 18GA NEEDLE HAS TO TRAVEL THE DISTANCE OF THE CATHETER AND IT WILL NOT FIT THROUGH THE CATHETER IF THERE IS ANY SKIVING, BENT OR THIN AREAS. FOR THE CATHETER TO BREAK IN THAT MANNER THERE HAS TO HAVE BEEN SOME CONTACT WITH A SHARP OBJECT TO CREATE AN INCISION. SOMETHING MUST HAVE HAPPENED AFTER THE CATHETER WAS INSERTED AND THE 18GA NEEDLE REMOVED. I EXPOSED A CATHETER TO TWICE THE HEAT EXPOSURE AS PER NORMAL PROCESS TO SEE IF THE CATHETER WOULD BECOME BRITTLE AND BREAK BY PULLING OR BENDING IT. THIS EXERCISE DID NOT CAUSE ANY BREAKAGE TO THE CATHETER. THERE IS NO KNOWN ROOT CAUSE FOR THIS SPECIFIC FAILURE MODE. IN SUMMARY, AS PER THE PHOTOS AND NOTES FROM THE EMAIL, THE CATHETER APPEARS TO HAVE BEEN SUCCESSFULLY INSERTED INTO THE PATIENT. THE POOR QUALITY OF THE PHOTOS PROVIDED DO NOT HELP IN CONFIRMING THE TYPE OF CUT THE CATHETER ENDURED TO HAVE BROKEN APART. THE STRENGTH OF THE CATHETER MATERIAL WILL NOT ALLOW IT TO BREAK APART WITHOUT THE INTERVENTION OF AN EXTERNAL SOURCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE A CAPA IS NOT REQUIRED AT THIS TIME. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AFTER SUBMITTING THE INITIAL MDR ON 4/14/2016, BD WAS MADE AWARE ON 5/9/2016 THAT THE CUSTOMER HAD SUBMITTED A VOLUNTARY MEDWATCH # MW5061560. THE INFORMATION CONTAINED IN THE MEDWATCH IS AS FOLLOWS: PHYSICIAN SURGICALLY INSTALLED (B)(4) BONNANO SUPRAPUBIC CATHETER ON (B)(6) 2015. CATHETER BENT UP INSIDE PT THAT DATE. PT NOTED EXTERIOR MOUNTING PLATE WAS AT AN ODD ANGLE (B)(6) 2015. PHYSICIAN NOTED SUPRAPUBIC CATHETER WAS BENT AND AT AN ODD ANGLE DURING OFFICE VISIT (B)(6) 2015. URINE LEAKING FROM BENEATH CATHETER SECURING PLATE (B)(6) 2015. SECOND PHSICIAN NOTED SUPRAPUBIC CATHETER WAS BENT DURING (B)(6) 2015 OFFICE VISIT. INTERIOR SUPRAPUBIC CATHETER SNAPPEDAT ONE OF THE BENDS INSIDE PT LATER IN THE DAY (B)(6) 2015. ATTEMPTED REMOVEAL OF SUPRAPUBIC CATHETER (B)(6) 2015, RESULTED IN ONLY 1 INCH OF CATHETERTHAT HAD BEEN INSIDE THE PT, STILL ATTACHJED TO PLATE WHEN EXTERIOR PLATE WAS LIFTED FROM THE PT. FRACTURED-OFF REMAINING 7 INCHES OF SUPRAPUBIC CATHETER REMAINED IN PT'S ABDOMINAL CAVITY AND BLADDER. PT WENT TO ER (B)(6) 2015WHERE X-RAYS CONFIRMED PRESENCE AND LOCATION OF FRACTURED-OFF SP CATHETER. SURGERY PERFORMED (B)(6) 2015, TO REMVEFRACTURED-OFF SUPRAPUBIC CATHETER FROM PT'S ABDOMINAL CAVITY AND BLADDER.

    Description of Event or Problem · 1

    THE FOLLOWING IS A TIMELINE OF EVENTS REPORTED BY A PATIENT (THE INITIAL REPORTER): ON (B)(6) 2015 - A BD BONNANO SUPRAPUBIC CATHETER TRAY WAS USED TO SURGICALLY PLACE A SUPRAPUBIC CATHETER INTO A PATIENT. THE PATIENT FOUND THE CATHETER TO BE AT AN ODD ANGLE AS IT DID NOT LAY FLAY AGAINST HIS ABDOMEN. ON (B)(6) 2015 - THE PATIENT HAD A POST-SURGICAL FOLLOW APPOINTMENT WITH HIS DOCTOR (DR. (B)(6)) AND WAS INFORMED THAT THE CATHETER WAS BENT. ON (B)(6) 2015 - THE PATIENT NOTED URINE AND BLOOD LEAKING FROM THE CATHETER INSERTION SITE AND ATTEMPTED TO CONTACT DR. (B)(6). ON (B)(6) 2015 - DR. (B)(6) CONTACTED THE PATIENT AND ADVISED HIM FOLLOW UP WITH A DR. (B)(6) AT (B)(6) AND AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2015. ON (B)(6) 2015 - THE PATIENT SAW DR. (B)(6), BUT DR. (B)(6) DECLINED TO REMOVE THE CATHETER. AT APPROXIMATELY 2:00 PM THAT DAY THE PATIENT FELT A "CRUNCH" IN HIS ABDOMEN BUT DID NOT OBSERVE ANYTHING DIFFERENT THAN WHAT WAS OBSERVED ON (B)(6) 2015. ON (B)(6) 2016 - THE PATIENT WAS EVALUATED IN AN EMERGENCY DEPARTMENT WHERE HE RECEIVED AN X-RAY THAT VISUALIZED A BROKEN CATHETER. THE PATIENT WAS REFERRED TO A UROLOGIST (DR. (B)(6)) TO HAVE THE BROKEN CATHETER SURGICALLY REMOVED. ON (B)(6) 2015 - THE PATIENT WAS EVALUATED BY DR. (B)(6), RECEIVED A CT SCAN, HAD BLOODWORK DONE, AND HAD SURGERY TO REMOVE THE BROKEN CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH # MW5061560: PHYSICIAN SURGICALLY INSTALLED (B)(4) BONNANO SUPRAPUBIC CATHETER ON (B)(6) 2015. CATHETER BENT UP INSIDE PT THAT DATE. PT NOTED EXTERIOR MOUNTING PLATE WAS AT AN ODD ANGLE (B)(6) 2015. PHYSICIAN NOTED SUPRAPUBIC CATHETER WAS BENT AND AT AN ODD ANGLE DURING OFFICE VISIT (B)(6) 2015. URINE LEAKING FROM BENEATH CATHETER SECURING PLATE (B)(6) 2015. SECOND PHYSICIAN NOTED SUPRAPUBIC CATHETER WAS BENT DURING (B)(6) 2015 OFFICE VISIT. INTERIOR SUPRAPUBIC CATHETER SNAPPED AT ONE OF THE BENDS INSIDE PT LATER IN THE DAY (B)(6) 2015. ATTEMPTED REMOVAL OF SUPRAPUBIC CATHETER (B)(6) 2015, RESULTED IN ONLY 1 INCH OF CATHETER THAT HAD BEEN INSIDE THE PT, STILL ATTACHED TO PLATE WHEN EXTERIOR PLATE WAS LIFTED FROM THE PT. FRACTURED-OFF REMAINING 7 INCHES OF SUPRAPUBIC CATHETER REMAINED IN PT'S ABDOMINAL CAVITY AND BLADDER. PT WENT TO ER (B)(6) 2015 WHERE X-RAYS CONFIRMED PRESENCE AND LOCATION OF FRACTURED-OFF SP CATHETER. SURGERY PERFORMED (B)(6) 2015, TO REMOVE FRACTURED-OFF SUPRAPUBIC CATHETER FROM PT'S ABDOMINAL CAVITY AND BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234331 BD BONNANO¿ SUPRAPUBIC CATHETER TRAY SUPRAPUBIC CATHETER TRAY FEZ BD CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention