BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7388723 · Received April 2, 2018

    Report

    Report Number
    1213809-2018-00209
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    March 14, 2018
    Report Date
    May 3, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO EVALUATION: ONE PHOTO WAS RECEIVED DEPICTING PRODUCT REPORTED TO BE FROM BATCH #6082996 AND #5334912 (P/N 301029). THE PRODUCT IS SEPARATED INTO FIVE BAGS CONTAINING VARYING QUANTITIES OF 10ML SYRINGES AND FOLDED LABELED PLASTIC BAGS. THE SYRINGES IN THE BAGS ARE LOOSE. THE STOPPERS OF ALL SYRINGES APPEAR TO BE IN THE BOTTOM OUT/ZERO LINE POSITION. SOME OF THE SYRINGES HAVE A PALE YELLOW/LIGHT BROWN SUBSTANCE RESIDUE VISIBLE BETWEEN THE STOPPER AND THE BARREL ROOF ¿ A SIGN OF HAVING BEEN USED. SIMILAR SUBSTANCE RESIDUE CAN BE OBSERVED IN AT LEAST ONE OF THE SYRINGES BEHIND THE STOPPER ON THE PLUNGER ROD. HOWEVER, THE LIGHT REFLECTION OF THE SAMPLE BAG¿S SURFACE MAKES THE SAMPLE EVALUATION DIFFICULT AND PHYSICAL SAMPLES OR ADDITIONAL PHOTOS WOULD BE REQUIRED FOR FURTHER ANALYSIS. IT IS ALSO UNKNOWN WHAT TYPE OF LEAKAGE THE END-USER IS REFERRING TO AND HOW THE PRODUCT WAS USED WHEN THE REPORTED FAILURE OCCURRED. FOUR OF THE FIVE SAMPLE BAGS HAVE PRODUCT LABELS INSIDE THAT READ ¿10 ML BD PLASTIPAK LUER-LOK SYRINGES¿ WITH UDI SCAN CODE. THE EXPIRATION DATE LISTED IS AUG-2021 WHICH DOES NOT MATCH EITHER OF THE 2 REPORTED BD CANAAN LOTS. THERE IS INSUFFICIENT INFORMATION FOR INVESTIGATION TO PROCEED ANY FURTHER. IT IS FURTHER COMPOUNDED BY QUESTIONABLE PRODUCT BEING PRESENTED IN THE PHOTOS. SAMPLE EVALUATION: A BOX WAS RECEIVED, IT CONTAINED 5 SAMPLE BAGS TOTALING 69 SYRINGES. SAMPLES WERE VISUALLY EVALUATED. EACH BAGS CONTAINED DIFFERENT NUMBER OF 10ML SYRINGES AND DRIED WHITE/YELLOW RESIDUE. THE WHITE AND YELLOW RESIDUE WAS FOUND THROUGHOUT THE BAGS' INSIDE SURFACE AND INSIDE MANY OF THE SYRINGES. THE RESIDUE WAS OBSERVED IN THE FLUID PATH, OUTSIDE THE FLUID PATH AND IN AT LEAST TWO CASES BETWEEN THE STOPPER RIBS AND UNDER THE STOPPER, INDICATING POTENTIAL LEAKAGE PAST STOPPER. HOWEVER, BATCH IDENTIFICATION LABELS SEEN IN THE PHOTO WERE APPARENTLY REMOVED FROM THE SAMPLES PRIOR TO ARRIVAL AT THE PLANT, THEREFORE IT COULD NOT BE CONFIRMED WHERE THE PRODUCT WAS MANUFACTURED. DHR REVIEW FOR BATCH 6082996 (P/N 301029): MANUFACTURING DATES: 4/14/2016 TO 4/18/2016. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6082996 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 5334912 (P/N 301029): MANUFACTURING DATES: 12/10/2015 TO 12/11/2015. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 5334912 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION. ROOT CAUSE WAS NOT DETERMINED FROM THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6082996. MEDICAL DEVICE EXPIRATION DATE: 02/28/2021. DEVICE MANUFACTURE DATE: 03/22/2016. MEDICAL DEVICE LOT #: 5334912. MEDICAL DEVICE EXPIRATION DATE: 11/30/2020. DEVICE MANUFACTURE DATE: 11/30/2015. 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 THE CUSTOMER IS EXPERIENCING LEAKING IN THE BD SYRINGE LUER-LOK¿ TIP. THE REPORTED MEDICATION LEAKING OUT IS CEFAZOLINE. NO REPORTED SERIOUS INJURY OR MEDICAL INTERVENTION NOTED. THE CUSTOMER REPORTS THEY HAVE 69 SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233846 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other