BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE

    MDR report key: 9639251 · Received January 28, 2020

    Report

    Report Number
    1213809-2020-00023
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 3, 2020
    Report Date
    February 18, 2020
    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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS AND ONE 3ML INTEGRA SYRINGE WITH NEEDLE ATTACHED IN AN OPENED BLISTER PACK FROM BATCH 9251667 (P/N 305270) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A SMALL, THIN, CLEAR PIECE OF FOREIGN MATTER OBSERVED ON THE STOPPER OF THE SYRINGE. IT APPEARED TO BE A PIECE OF PLASTIC AND WAS LARGER THAN LEVEL 2 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. THERE WAS ALSO A SMALL AMOUNT OF PLASTIC SHAVED OFF THE TOP OF THE BARREL THAT IS CONSISTENT WITH THE SIZE OF THE OBSERVED FOREIGN MATTER. 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. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER IN THE FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT WAS LIKELY DUE TO THE TOP OF THE BARREL BEING DAMAGE DURING CAUSE THE PLASTIC SHARD TO BECOME LOOSE THEN THE PLUNGER ROD PUSHING IT INTO THE SYRINGE DURING INSERTION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9251667 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE HAD FOREIGN MATTER IN IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305270 BATCH NO.: 9251667. IT WAS REPORTED THAT THE 3ML BD INTEGRA SYRINGE APPEARED TO CONTAIN A FOREIGN MATTER THAT LOOKED LIKE A PLASTIC SHAVING. PER EMAIL: I HAVE CONCERNS ABOUT FOREIGN MATTER IN THE BD INTEGRA 3ML 25G 1" SYRINGE. IT APPEARS TO CONTAIN A PLASTIC SHAVING.

    Additional Manufacturer Narrative · 1

    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 HAD FOREIGN MATTER IN IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305270 BATCH NO.: 9251667. IT WAS REPORTED THAT THE 3ML BD INTEGRA SYRINGE APPEARED TO CONTAIN A FOREIGN MATTER THAT LOOKED LIKE A PLASTIC SHAVING. PER EMAIL: I HAVE CONCERNS ABOUT FOREIGN MATTER IN THE BD INTEGRA 3ML 25G 1" SYRINGE. IT APPEARS TO CONTAIN A PLASTIC SHAVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103480 BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305270 9251667 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other