BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 9873247 · Received March 24, 2020

    Report

    Report Number
    1213809-2020-00201
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 4, 2020
    Report Date
    April 22, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052692
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 04/06/2020. H.6. INVESTIGATION: FIVE 3ML INTEGRA SYRINGES IN FULLY SEALED BLISTER PACKS FROM BATCH 9232755 (P/N 305269) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ALL FIVE OF THE SYRINGES HAD A SMALL AMOUNT OF HUB DAMAGE WHERE THE SHIELD CONNECTS TO THE HUB. ONE OF THE SYRINGES ALSO HAD A SMALL DEFORMATION ON THE TOP EDGE OF THE HUB WHERE IT CONTACTS THE SYRINGE. ALL FIVE SYRINGES WERE TESTED FOR LEAKAGE AT THE LUER CONNECTION WITH NO LEAKAGE OBSERVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE SYRINGE IS LEAKING AT CONNECTION SITE WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE IS LEAKING AROUND THE NEEDLE AND SQUIRTS OUT FORCEFULLY FROM THE CONNECTION DURING USE. THESE ARE USED WITH LIDOCAINE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9232755. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-08-20. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN." 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 DURING USE THE SYRINGE IS LEAKING AT CONNECTION SITE WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE IS LEAKING AROUND THE NEEDLE AND SQUIRTS OUT FORCEFULLY FROM THE CONNECTION DURING USE. THESE ARE USED WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339662 BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305269 SEE H.10 30382903052692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other