BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 SB NS

    MDR report key: 10624512 · Received October 4, 2020

    Report

    Report Number
    1911916-2020-00928
    Event Type
    Malfunction
    Date Received
    October 4, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 16, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9226295, MEDICAL DEVICE EXPIRATION DATE: 2024-07-31, DEVICE MANUFACTURE DATE: 2019-08-14, MEDICAL DEVICE LOT #: 0013587, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-01-13. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 9226295 AND 0013587. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 1 PHYSICAL SAMPLE AND 6 PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PHYSICAL SAMPLE, A VISUAL INSPECTION WAS PREFORMED WITH A MAGNIFIER LENS AND THE NEEDLE AND PLASTIC SHIELD HAVE NO DEFECTS. HOWEVER, BASED ON THE PHOTOGRAPHS PROVIDED, A PLASTIC SHIELD WITH EMBEDDED DEGRADED RESIN AND NEEDLE WITH FOREIGN MATTER ADHERED WAS SHOWN. THE MATTER WAS NOT ABLE TO BE IDENTIFIED BASED ON THE PHOTO. THE CAUSE OF THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE MOLDING PROCESS, WHERE THE DEGRADED RESIN BUILDS UP IN THE HOT RUNNER SYSTEM OF THE MOLD AND PRESS AND CAN BREAK LOOSE AND BECOME MOLDED IN THE COMPONENTS. THE CAUSE FOR THE FOREIGN MATTER ADHERED TO THE NEEDLE COULD NOT BE DETERMINED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLES 18X1-1/2 SB NS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303013 BATCH NO: 9226295, 0013587. EVENT DESCRIPTION: ASSOCIATE FROM INSIDE SALES STATING: END USER FOUND BLACK SPOTS ALL OVER A HYPODERMIC NEEDLE WHILE IN THE MIDDLE OF THE PROCEDURE. THEY STOPPED THE PROCEDURE AND OPENED ANOTHER TRAY. THE COMPLAINT SHOWS FOREIGN DEBRIS INSIDE THE CAP OF THE NEEDLE. ADDITIONALLY, WE INSPECTED A DIFFERENT LOT OF NEEDLES AND FOUND THE SAME TYPE OF DEBRIS IN SOME OF THE NEEDLES IN INVENTORY. THE AFFECTED LOTS ARE BATCH 9226295 AND 0013587. FOLLOW UP RESPONSE: HOW MANY ITEMS WERE INVOLVED? TWO NEEDLES WERE FOUND WITH A FOREIGN MATERIAL ON THEM. (ONE BY OUR CUSTOMER AND ONE FOUND IN INVENTORY). WE ARE CONTINUING TO INSPECT FOR THIS ISSUE. WHAT IS THE DATE OF THE EVENT? (B)(6) 2020 (CUSTOMER COMPLAINT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089049 NEEDLE 18X1-1/2 SB NS NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other