BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE W/ BD LUER-LOK TIP

    MDR report key: 9444709 · Received December 10, 2019

    Report

    Report Number
    1911916-2019-01299
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO (2) SAMPLES AND FIVE (5) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) SAMPLE WAS RETURNED IN AN UNOPENED BLISTER PACK AND THE SECOND (2ND) SAMPLE WAS RETURNED WITHOUT A BLISTER PACK. BOTH SAMPLES WERE VISUALLY EXAMINED USING UNAIDED VISION. THE SAMPLE IN THE UNOPENED BLISTER PACK DOES NOT HAVE ANY FOREIGN MATTER ON IT. THE SAMPLE WHICH WAS RETURNED WITHOUT A BLISTER PACK HAS BROWN FOREIGN MATTER EMBEDDED IN THE SYRINGE TIP, BODY, AND FLANGE. FIVE (5) PHOTOS WERE ALSO PROVIDED BY THE CUSTOMER FOR INVESTIGATION. FOUR (4) OF THE PHOTOS SHOW THE RETURNED SAMPLE WHICH HAS EMBEDDED FOREIGN MATTER IN THE SYRINGE TIP, BARREL, AND FLANGE FROM VARIOUS ANGLES. THE FIFTH (5TH) PHOTO SHOWS PART OF THE BLISTER PACK WHICH PROVIDES THE LOT NUMBER AND EXPIRATION DATE FOR THE SYRINGES ASSOCIATED WITH THIS COMPLAINT. EMBEDDED FM CAN OCCUR AT THE STARTUP OF THE INJECTION MOLDING PROCESS. SOLIDIFIED RESIN WITHIN THE MOLD AND MOLDING PRESS MAY BECOME DISCOLORED OR DEGRADED WHEN REHEATED. THIS IS A COSMETIC DEFECT AND DOES NOT AFFECT THE INTEGRITY OF THE SYRINGE. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE W/ BD LUER-LOK¿ TIP HAD FOREIGN MATTER ON THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653 BATCH NO: 9120814. IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED A 60ML PACKAGE AND FOUND THE SYRINGE PICTURED. IT HAS WHAT LOOKS LIKE CHOCOLATE WITHIN THE PLASTIC ALL OVER THE SYRINGE. VERBATIM: I WOULD LIKE TO ALERT BD ABOUT AN ISSUE IDENTIFIED IN OUR PHARMACY IV ROOM. TODAY WE OPENED A 60ML PACKAGE AND FOUND THE SYRINGE. IT HAS WHAT LOOKS LIKE CHOCOLATE WITHIN THE PLASTIC ALL OVER THE SYRINGE. IT IS NOT ANYTHING THAT I CAN SCRAPE OFF - IT SEEMS TO BE EMBEDDED IN THE PLASTIC. TECHS ARE BEING ASKED TO INSPECT ALL SYRINGES BEFORE USING THEM. WE ONLY HAD A FEW OF THIS LOT NUMBER LEFT AS THE REST WERE ALREADY USED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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¿ SYRINGE W/ BD LUER-LOK¿ TIP HAD FOREIGN MATTER ON THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309653, BATCH NO: 9120814. IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED A 60ML PACKAGE AND FOUND THE SYRINGE PICTURED. IT HAS WHAT LOOKS LIKE CHOCOLATE WITHIN THE PLASTIC ALL OVER THE SYRINGE. VERBATIM: I WOULD LIKE TO ALERT BD ABOUT AN ISSUE IDENTIFIED IN OUR PHARMACY IV ROOM. TODAY WE OPENED A 60ML PACKAGE AND FOUND THE SYRINGE. IT HAS WHAT LOOKS LIKE CHOCOLATE WITHIN THE PLASTIC ALL OVER THE SYRINGE. IT IS NOT ANYTHING THAT I CAN SCRAPE OFF - IT SEEMS TO BE EMBEDDED IN THE PLASTIC. TECHS ARE BEING ASKED TO INSPECT ALL SYRINGES BEFORE USING THEM. WE ONLY HAD A FEW OF THIS LOT NUMBER LEFT AS THE REST WERE ALREADY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243298 BD SYRINGE W/ BD LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9120814 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other