BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL 32GA 4MM 14BAG 700CASE JP

    MDR report key: 8778611 · Received July 10, 2019

    Report

    Report Number
    9616656-2019-00609
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 8122798 D.4. MEDICAL DEVICE EXPIRATION DATE: 4/30/2023 H.4. DEVICE MANUFACTURE DATE: 5/2/2018 H.6. INVESTIGATION SUMMARY: FIVE OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8122798, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND IT WAS OBSERVED THAT THE NON PATIENT END OF THE CANNULA WAS BENT ON ALL FIVE SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TESTING COULD BE CARRIED OUT. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CONCLUSION: AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PEN NDL 32GA 4MM 14BAG 700CASE JP THE DRUG DID NOT COME OUT DURING AIR PURGE. IT WAS REPORTED THAT THERE WERE FIVE SYRINGES WITH THIS CONDITION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRUG DIDN'T COME OUT DURING AIR PURGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PEN NDL 32GA 4MM 14BAG 700CASE JP THE DRUG DID NOT COME OUT DURING AIR PURGE. IT WAS REPORTED THAT THERE WERE FIVE SYRINGES WITH THIS CONDITION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRUG DIDN'T COME OUT DURING AIR PURGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572692 BD PEN NDL 32GA 4MM 14BAG 700CASE JP PEN NEEDLE FMI BECTON DICKINSON AND CO. 8122798

    Patients

    Seq Age Sex Outcome Treatment
    1 Other