BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ VETERINARY INSULIN SYRINGE

    MDR report key: 8249354 · Received January 15, 2019

    Report

    Report Number
    1920898-2018-01011
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    December 27, 2018
    Report Date
    February 21, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903230006
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. SEVERITY RANKING IS S1. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR STOPPER DAMAGED AND PLUNGER ROD DIFFICULT TO MOVE ON LOT # 7202612. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7202612 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: ADDITIONALLY, THE EVALUATION OF THE SUBMITTED DEVICE CLEARLY DEMONSTRATED THE REPORTED ISSUE, AND IN RESPONSE OUR QUALITY ENGINEERS REVIEWED THE MANUFACTURING PROCESS FOR POTENTIAL OPPORTUNITIES TO GENERATE THIS TYPE OF DAMAGE. DURING THE REVIEW OUR ENGINEERS WERE UNABLE TO FIND ANY SOURCES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE OBSERVED, AND FOUND THE APPROPRIATE TESTS TO BE IN PLACE DURING PRODUCTION TO IDENTIFY FAULTY UNITS PRIOR TO PACKAGING AND SHIPMENT OF THE DEVICE. ROOT CAUSE DESCRIPTION: BASED ON OUR FINDINGS, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 3/10CC, 12.7MM, 29G U40 BD PET SYRINGES IN AN OPEN POLY BAG FROM LOT # 7202612. CUSTOMER STATES THAT THE STOPPERS WERE CROOKED AND WOULD NOT ALLOW TO PULL PLUNGER DOWN. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED A DEFORMED STOPPER IN THE BARREL. A DEFORMED STOPPER COULD CAUSE THE PLUNGER ROD TO BE DIFFICULT TO MOVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7202612 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200701492, 200701268] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSES FOR A DAMAGED STOPPER INCLUDE: THIS CONDITION IS REFERRED TO AS A ROLLED STOPPER WHICH CAN OCCUR DURING THE ASSEMBLY PROCESS, WHEN THE PLUNGER ROD IS BEING ASSEMBLED IN THE BARREL AND THERE IS INADEQUATE (NOT ENOUGH) LUBE PRESENT IN THE BARREL ID (INNER DIAMETER) AND OR THE STOPPER ITSELF DOES NOT HAVE ENOUGH LUBE ON IT. AS A RESULT, THE STOPPER DOES NOT MOVE FREELY IN THE BARREL AND CAN BECOME STUCK AND DEFORMED. THERE IS ALSO THE POSSIBILITY THAT THE STOPPER STARTS OUT BEING MISALIGNED ON THE END OF THE PLUNGER ROD AND THEN GETS ROLLED AS IT IS BEING INSERTED INSIDE THE BARREL. ROLLED STOPPERS CAN ALSO BE CAUSED BY PARTIALLY PEELING OFF THE STOPPER BEFORE INSERTION INTO THE SYRINGE BARREL. AS PER SUPPLIER, IMPROPER STACKING OF RUBBER SHEETS IN AUTOCLAVE CART, CAUSING PINCHING/DEFORMITY. CAPA 122939 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ VETERINARY INSULIN SYRINGES EXPERIENCED DAMAGE TO THEIR STOPPERS MAKING THEM DIFFICULT TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ VETERINARY INSULIN SYRINGES EXPERIENCED DAMAGE TO THEIR STOPPERS MAKING THEM DIFFICULT TO USE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VETERINARY INSULIN SYRINGES EXPERIENCED DAMAGE TO THEIR STOPPERS MAKING THEM DIFFICULT TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44168 BD¿ VETERINARY INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7202612 00382903230006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other