BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 19731183 · Received July 12, 2024

    Report

    Report Number
    1911916-2024-00493
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 26, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305180 AND LOT NUMBER 4031512. 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. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL: 305180; BATCH#: 4031512. IT WAS REPORTED BY THE CUSTOMER THAT EXPRESSED THAT THE NEEDLE WAS EITHER TOO SHARP OR TOO BLUNT AS THEY HAD EXPERIENCED THE NEEDLE PUSHING SOME OF THE RUBBER FROM THE MEDICATION VIAL INTO THE ACTUAL MEDICATION, THEY STATED THAT THIS HAPPENED TO 2 SEPARATE MEDICATIONS. VERBATIM: XXXI JUST HAD A COMPLAINT FROM THE OR ABOUT ITEM BD305180, THEY HAD EXPRESSED THAT THE NEEDLE WAS EITHER TOO SHARP OR TOO BLUNT AS THEY HAD EXPERIENCED THE NEEDLE PUSHING SOME OF THE RUBBER FROM THE MEDICATION VIAL INTO THE ACTUAL MEDICATION, THEY STATED THAT THIS HAPPENED TO 2 SEPARATE MEDICATIONS. NOT SURE IF YOU HAVE HEARD ANYTHING LIKE THIS FROM OTHER USERS. LOT # 4031512. PLEASE ADVISE.

    Description of Event or Problem · 0

    MATERIAL: 305180 BATCH#: 4031512. IT WAS REPORTED BY THE CUSTOMER THAT EXPRESSED THAT THE NEEDLE WAS EITHER TOO SHARP OR TOO BLUNT AS THEY HAD EXPERIENCED THE NEEDLE PUSHING SOME OF THE RUBBER FROM THE MEDICATION VIAL INTO THE ACTUAL MEDICATION, THEY STATED THAT THIS HAPPENED TO 2 SEPARATE MEDICATIONS. VERBATIM: XXXI JUST HAD A COMPLAINT FROM THE OR ABOUT ITEM BD305180, THEY HAD EXPRESSED THAT THE NEEDLE WAS EITHER TOO SHARP OR TOO BLUNT AS THEY HAD EXPERIENCED THE NEEDLE PUSHING SOME OF THE RUBBER FROM THE MEDICATION VIAL INTO THE ACTUAL MEDICATION, THEY STATED THAT THIS HAPPENED TO 2 SEPARATE MEDICATIONS. NOT SURE IF YOU HAVE HEARD ANYTHING LIKE THIS FROM OTHER USERS. LOT # 4031512. PLEASE ADVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315209 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4031512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown