BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32X4 LA 5B

    MDR report key: 9194346 · Received October 15, 2019

    Report

    Report Number
    9616656-2019-00995
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 30, 2019
    Report Date
    November 18, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (43) SEALED 4MM, 32G PEN NEEDLES WITH THE SHELF CARTON FROM LOT # 8233916 AND (21) 4MM, 32G PEN NEEDLES (1 OPEN, 20 SEALED) WITH THE SHELF CARTON FROM LOT # 8233914. CUSTOMER STATES THAT IN THE BOXES THERE IS THE IMPRESSION THAT ANTS ENTERED THE BOX AND CREATED A NEST. ALL RETURNED SAMPLES AND BOTH RETURNED SHELF CARTONS WERE EXAMINED AND EXHIBITED DARK MATERIAL IN THE SHELF CARTON AND ON THE OUTER SURFACES OF THE TEAR DROP LABELS AND OUTER COVERS. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY BLOOD, WHICH WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. USER ERROR AS THE PRODUCT WOULD NOT HAVE ACQUIRED BLOOD IN THE SHELF CARTON AND ON THE PEN NEEDLES FROM THE MANUFACTURING PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NEEDLE 32X4 LA 5B EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TELEPHONE CONTACT MADE ON (B)(6)2019 AT 4:37 PM. CUSTOMER REPORTED THAT IN THE BOXES THERE IS THE IMPRESSION THAT ANTS ENTERED THE BOX AND CREATED A NEST. FOREIGN MATERIAL IS PRESENT IN THE BOXES AND TAPES THAT SEAL THE NEEDLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8233914, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2018-08-21, MEDICAL DEVICE LOT #: 8233916, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2018-08-21.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NEEDLE 32X4 LA 5B EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TELEPHONE CONTACT MADE ON (B)(6) 2019 AT 4:37 PM. CUSTOMER REPORTED THAT IN THE BOXES THERE IS THE IMPRESSION THAT ANTS ENTERED THE BOX AND CREATED A NEST. FOREIGN MATERIAL IS PRESENT IN THE BOXES AND TAPES THAT SEAL THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983900 PEN NEEDLE 32X4 LA 5B PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other