BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8112702 · Received November 28, 2018

    Report

    Report Number
    1213809-2018-00848
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 8, 2018
    Report Date
    February 5, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MULTIPLE SEALED SAFETYGLIDE NEEDLE PACKAGES FROM MULTIPLE BATCHES WERE RECEIVED IN TWO LARGE PLASTIC ZIP LOCK BAGS. IT IS NOT CLEAR WHY THE SAMPLES FROM ADDITIONAL BATCHES WERE SENT BESIDES THE 2 COMPLAINT BATCHES AND WHETHER THEY WERE INTENDED TO SERVE AS GOOD EXAMPLES OR NOT. 1 FROM BATCH #7235605, 1 FROM BATCH #7300879, 1 FROM BATCH #7300894 , 6 FROM BATCH #8029991, 14 F FROM BATCH #8057752, 3 FROM BATCH #8088825, 3 FROM BATCH #8088828, 2 FROM BATCH #8117597, 212 FROM BATCH #8143741, 27 FROM BATCH #8143742. EACH PACKAGE WAS OPENED AND PRODUCT INSIDE EVALUATED FOR THE REPORTED CONDITIONS. NO BENT NEEDLES NOR FOREIGN MATTER WAS OBSERVED IN ANY OF THE RETURNED SAMPLES. NO DEFECTS WERE FOUND. 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 "FIBER" WAS FOUND ON THE BD SAFETYGLIDE¿ NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8143741. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-05-23. MEDICAL DEVICE LOT #: 8187582. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-07-06. 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 "FIBER" WAS FOUND ON THE BD SAFETYGLIDE¿ NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949155 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10. 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other