BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17865284 · Received October 3, 2023

    Report

    Report Number
    1911916-2023-00721
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 9, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 3083951. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    B.3. 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 ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3024945. D4. MEDICAL DEVICE EXPIRATION DATE: 29FEB2028. H4. DEVICE MANUFACTURE DATE: 24JAN2023. D4. MEDICAL DEVICE LOT #: 3083951. D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2028. H4. DEVICE MANUFACTURE DATE: 24MAR2023. H.3. 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 · 0

    IT WAS REPORTED WHILE USING 4 OF THE BD SAFETYGLIDE¿ NEEDLE THE NEEDLE WAS BLOCKED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PLEASE SEE ATTACHED R/T DEFECTIVE NEEDLE; PROVIDER REPORTS RESISTANCE AND UNABLE TO PUSH MEDICATION. THIS HAS HAPPENED IN THE PAST AND WAS REPORTED. PLEASE ADVISE NEXT STEPS. RESPONSE RECEIVED ON 25-SEP-2023. WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 4 OF THE BD SAFETYGLIDE¿ NEEDLE THE NEEDLE WAS BLOCKED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PLEASE SEE ATTACHED R/T DEFECTIVE NEEDLE; PROVIDER REPORTS RESISTANCE AND UNABLE TO PUSH MEDICATION. THIS HAS HAPPENED IN THE PAST AND WAS REPORTED. PLEASE ADVISE NEXT STEPS. RESPONSE RECEIVED ON (B)(6) 2023. WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553758 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown