BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 9539037 · Received January 2, 2020

    Report

    Report Number
    1213809-2019-01323
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 5, 2019
    Report Date
    January 23, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS AND 18 USED 10ML SYRINGES IN THREE ZIP LOCK BAGS, FILLED TO NOMINAL CAPACITY WITH CLEAR LIQUID MEDICATION, WERE RECEIVED. TWO BAGS WERE HAND MARKED TO BE LOT #9170806, WHILE ONE BAG WAS MARKED TO BE LOT #9078951. THE SAMPLES WERE VISUALLY EVALUATED THROUGH THE BAG WITH THE AID OF ILLUMINATED MAGNIFICATION. ALL OF THE SAMPLES EXHIBITED SIGNS OF LEAKAGE PAST STOPPER, WITH MOST SHOWING EITHER LIQUID OR DRIED RESIDUE PAST THE SECOND STOPPER RIB. NO FOREIGN MATTER WAS OBSERVED IN THE FLUID PATH NOR BETWEEN ANY OF THE STOPPER RIBS. NO STOPPER DEFECTS WERE OBSERVED. PRESSING AND PULLING ON THE PLUNGER ROD¿S THUMB REST IN SEVERAL OF THE SAMPLES, THE SEAL APPEARED TO REMAIN INTACT WITH NO ADDITIONAL LEAKAGE FORMING. NO MANUFACTURING DEFECTS WERE OBSERVED IN THE SAMPLES RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 10ML SYRINGE LUER-LOK¿ TIP LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309605; BATCH NO.: 9170806, 9078951. IT WAS REPORTED THE SYRINGES ARE LEAKING PAST THE STOPPER. I SENT THEM THE SHIPPING LABEL TO SEND ADDITIONAL SAMPLES FOR THE COMPLAINTS WE ALREADY HAVE LOGGED. WE NEED TO HAVE A COMPLAINT CAPTURED FOR THE ADDITIONAL LOTS HE MENTIONS AS WELL AS THE BD 10 ML, ALL HAVING ISSUES WITH LEAKAGE PAST THE STOPPER. HE ALSO MENTIONS THEY ARE SEEING IT ON ADDITIONAL LOTS BUT THEY DO NOT HAVE SAMPLES AVAILABLE. AT THIS POINT I AM NOT AWARE IF THEY HAVE SEEN THIS ON DIFFERENT OCCURRENCE DATES. I HAVE SENT HIM AN ADDITIONAL EMAIL TO LET HIM KNOW THIS INFORMATION WAS FORWARD TO OUR COMPLAINTS TEAM FOR PROCESSING.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9170806, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-06-19, MEDICAL DEVICE LOT #: 9078951, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-19. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 10ML SYRINGE LUER-LOK¿ TIP LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309605 BATCH NO.: 9170806, 9078951. IT WAS REPORTED THE SYRINGES ARE LEAKING PAST THE STOPPER. I SENT THEM THE SHIPPING LABEL TO SEND ADDITIONAL SAMPLES FOR THE COMPLAINTS WE ALREADY HAVE LOGGED. WE NEED TO HAVE A COMPLAINT CAPTURED FOR THE ADDITIONAL LOTS HE MENTIONS AS WELL AS THE BD 10 ML, ALL HAVING ISSUES WITH LEAKAGE PAST THE STOPPER. HE ALSO MENTIONS THEY ARE SEEING IT ON ADDITIONAL LOTS BUT THEY DO NOT HAVE SAMPLES AVAILABLE. AT THIS POINT I AM NOT AWARE IF THEY HAVE SEEN THIS ON DIFFERENT OCCURRENCE DATES. I HAVE SENT HIM AN ADDITIONAL EMAIL TO LET HIM KNOW THIS INFORMATION WAS FORWARD TO OUR COMPLAINTS TEAM FOR PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4776 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309605 SEE H.10 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other