BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE 32GX4MM

    MDR report key: 11033438 · Received December 17, 2020

    Report

    Report Number
    2243072-2020-02094
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 16, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO ACTUAL DEFECT PARTS RETUNED FOR FURTHER INVESTIGATION, SO A COMPREHENSIVE EVALUATION AND INVESTIGATION CANNOT BE CONCLUDED AT THE MOMENT. DHR AND MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMAL WAS FOUND. TESTED 7PCS RETENTION SAMPLES OF NP-ENDED NEEDLE APPEARANCE, NP GAP AND THREAD.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT PRIOR TO USE THE NEEDLE WOULD NOT ATTACH TO THE PEN WITH A BD PEN NEEDLE 32GX4MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND THAT THE NEEDLE COULD NOT BE TIGHTENED TO THE INJECTION PEN DURING SUBCUTANEOUS DRUG THERAPY DUE TO THE CONDITION. D.3. MEDICAL DEVICE MANUFACTURER: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. ¿ SUZHOU, CHINA / 215021 D.4 MEDICAL DEVICE CATALOG #: 329491 D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-04-30 G.2 MANUFACTURING LOCATION: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. ¿ SUZHOU, CHINA / 215021 G.5. PMA / 510(K)#: NA H.4. DEVICE MANUFACTURE DATE: 2020-05-28

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE NEEDLE WOULD NOT ATTACH TO THE PEN WITH A BD PEN NEEDLE 32GX4MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND THAT THE NEEDLE COULD NOT BE TIGHTENED TO THE INJECTION PEN DURING SUBCUTANEOUS DRUG THERAPY DUE TO THE CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE NEEDLE WOULD NOT ATTACH TO THE PEN WITH A BD PEN NEEDLE 32GX4MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND THAT THE NEEDLE COULD NOT BE TIGHTENED TO THE INJECTION PEN DURING SUBCUTANEOUS DRUG THERAPY DUE TO THE CONDITION.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED, AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE NEEDLE WOULD NOT ATTACH TO THE PEN WITH AN UNSPECIFIED BD PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH, "IT WAS FOUND THAT THE NEEDLE COULD NOT BE TIGHTENED TO THE INJECTION PEN DURING SUBCUTANEOUS DRUG THERAPY DUE TO THE CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493003 BD PEN NEEDLE 32GX4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 0065884

    Patients

    Seq Age Sex Outcome Treatment
    1