BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE W/ DETACHABLE NEEDLE

    MDR report key: 9364161 · Received November 22, 2019

    Report

    Report Number
    1213809-2019-01175
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE WAS DAMAGED AND LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305270 BATCH, NO: 9093524 & UNKNOWN. IT WAS REPORTED THAT SYRINGES ARE LEAKING BECAUSE OF A PLASTIC PIECE NEAR THE HUB. SYRINGES ARE LEAKING BECAUSE OF A PLASTIC PIECE NEAR THE HUB. HAS OCCURRED WITH PREVIOUS LOT NUMBER. NO SPECIFIC DATES. SAMPLE FROM LOT AVAILABLE.

    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 #: 9093524, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-04-03, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE WAS DAMAGED AND LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305270 BATCH NO: 9093524 & UNKNOWN. IT WAS REPORTED THAT SYRINGES ARE LEAKING BECAUSE OF A PLASTIC PIECE NEAR THE HUB. SYRINGES ARE LEAKING BECAUSE OF A PLASTIC PIECE NEAR THE HUB. HAS OCCURRED WITH PREVIOUS LOT NUMBER. NO SPECIFIC DATES. SAMPLE FROM LOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161117 BD INTEGRA SYRINGE W/ DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other