BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PENNEEDLE 31X8 100

    MDR report key: 12277931 · Received August 4, 2021

    Report

    Report Number
    2243072-2021-02021
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 6, 2021
    Report Date
    September 17, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PENNEEDLE¿ 31X8 100 EXPERIENCED A CANNULA THAT BROKE OFF. THE PATIENT RECEIVED UNSPECIFIED SURGICAL INTERVENTION AS A RESULT OF THE PRODUCT DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKEN OFF AND REMAINED IN THE BODY (SURGERY). D.1. MEDICAL DEVICE BRAND NAME: BD PENNEEDLE¿ 31X8 100. D.2. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. (DUN LAOGHAIRE). D.4. MEDICAL DEVICE CATALOG #: 325105. D.4. MEDICAL DEVICE LOT #: 8135673. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2023. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/2/2021. G.1. MANUFACTURING LOCATION: BECTON DICKINSON AND CO. (DUN LAOGHAIRE). G.4. PMA / 510(K)#: K162516. H.4. DEVICE MANUFACTURE DATE: 5/15/2018. H.6. INVESTIGATION: FIFTY ONE SEALED 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8135673, CAT. NO. 325105. VISUAL EXAMINATION WAS CARRIED OUT ON THIRTY SAMPLES AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED ON THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PENNEEDLE¿ 31X8 100 EXPERIENCED A CANNULA THAT BROKE OFF. THE PATIENT RECEIVED UNSPECIFIED SURGICAL INTERVENTION AS A RESULT OF THE PRODUCT DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKEN OFF AND REMAINED IN THE BODY (SURGERY).

    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 THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD PEN NEEDLE EXPERIENCED A CANNULA THAT BROKE OFF. THE PATIENT RECEIVED UNSPECIFIED SURGICAL INTERVENTION AS A RESULT OF THE PRODUCT DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKEN OFF AND REMAINED IN THE BODY (SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170571 BD PENNEEDLE 31X8 100 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8135673

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention