BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT)

    MDR report key: 17222059 · Received June 28, 2023

    Report

    Report Number
    9616656-2023-00664
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 4, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES/PHOTOS WERE RETURNED FOR INVESTIGATION. 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. THIS COMPLAINT WAS CONFIRMED TO BE A PACKAGING GRAPHICS ERROR THEREFORE A REVIEW OF THE PACKAGING PROCESS AT THE SITE IS NOT REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) THE LABEL INFORMATION WAS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE CUSTOMER INFORMED US THAT THE FOLLOWING PRODUCTS ARE LABELED WITH A WRONG PZN: WE HAVE SUBSEQUENTLY HAD TO ESTABLISH THAT THE FOLLOWING PRODUCT IS LABELLED WITH A WRONG PZN: ART. 329917, CORRECT PZN: 15320182, WRONG LABELLING ON THE PACKAGE PZN: 15320176. DELIVERY NO. 601328 ORDER NO. PSN-155670 40 X 100 BD SAFEASSIST 30G SICH PEN NADELN 8MM PZN: 15320182 ART. 329917 CHARGE NR. 3010167. DELIVERY NO. 598484 ORDER NO. PSN-155584 40 X 100 BD SAFEASSIST 30G SICH PEN NADELN 8MM PZN: 15320182 ART. 329917 CHARGE NR. 3010167. DELIVERY NO. 595766 ORDER NO. PSN-155497 RESTMENGE 53 X 100 BD SAFEASSIST 30G SICH PEN NADELN 8MM PZN: 15320182 ART. 329917 CHARGE NR. 3010167.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) THE LABEL INFORMATION WAS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE CUSTOMER INFORMED US THAT THE FOLLOWING PRODUCTS ARE LABELED WITH A WRONG PZN: WE HAVE SUBSEQUENTLY HAD TO ESTABLISH THAT THE FOLLOWING PRODUCT IS LABELLED WITH A WRONG PZN: ART. (B)(4), CORRECT PZN: (B)(4), WRONG LABELLING ON THE PACKAGE PZN: (B)(4). DELIVERY NO. (B)(4) ORDER NO. (B)(4). 40 X 100 BD SAFEASSIST 30G SICH PEN NADELN 8MM PZN: (B)(4) ART. (B)(4) CHARGE NR. (B)(4). DELIVERY NO. (B)(4) ORDER NO. (B)(4). 40 X 100 BD SAFEASSIST 30G SICH PEN NADELN 8MM PZN: (B)(4) ART. (B)(4) CHARGE NR. (B)(4). DELIVERY NO. (B)(4) ORDER NO. (B)(4). RESTMENGE 53 X 100 BD SAFEASSIST 30G SICH PEN NADELN 8MM PZN: (B)(4) ART. (B)(4) CHARGE NR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308513 BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3010167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown