BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PRO PEN NEEDLE

    MDR report key: 15408141 · Received September 13, 2022

    Report

    Report Number
    9616656-2022-00979
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 16, 2022
    Report Date
    October 10, 2022
    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

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOTS WERE REPORTED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ PRO PEN NEEDLES HAD DIFFERING EXPIRATION DATES. THIS OCCURRED IN LOTS 9141582, 8205964, AND 6224650. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9141582 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024 H.4. DEVICE MANUFACTURE DATE: 21-MAY-2019 D.4. THE REPORTED LOTS 8205964 AND 6224650 WERE NOT FOUND FOR THE REPORTED CATALOG# 320561.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES . D10: RETURNED TO MANUFACTURER ON: 05OCT2022. ONE OPEN 32G X 4MM PEN NEEDLE CARTON WAS RETURNED FROM LOT. NO. 9141582, CAT. NO. 320561 ALONG WITH EIGHTY FOUR SEALED 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 9141582, NINE 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 8205964 AND FOUR 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 6224650. VISUAL EXAMINATION OF ALL RETURNED SAMPLES WAS CARRIED OUT AND IT WAS OBSERVED THAT THE SAMPLES FROM LOT. NO. 6224650 WERE EXPIRED. NO ISSUES WERE OBSERVED WITH SAMPLES FROM LOT. NO. 9141582 AND 8204964. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. LOT. NO. 9141582 WAS MANUFACTURED ON LINE 24, 26 TO 28 JUNE 2019 AND PACKAGED ON 654 29TH JUNE TO 07 JULY 2019. EXPIRY DATE MAY 2024. LOT. NO. 8205964 WAS MANUFACTURED ON LINE 20, 22ND TO 28TH SEPTEMBER 2018 AND PACKAGED ON 656 SEPTEMBER 29, 2018. EXPIRY DATE AUGUST 2023. LOT. NO. 6224650 WAS MANUFACTURED IN DROGHEDA 22ND SEPTEMBER TO 24TH SEPTEMBER 2016. EXPIRY DATE JULY 2021. LOT. NO. 6224650 HAS BEEN OUT IN THE MARKET SINCE 2016 THEREFORE IT HAS EXPIRED. LOT. NO. 9141582 AND LOT. NO. 8205964 HAVE NOT YET EXPIRED THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ PRO PEN NEEDLES HAD DIFFERING EXPIRATION DATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY INFORMS US THAT IN THE PEN NEEDLE PACKAGE, THERE WERE NEEDLES WITH EXPIRATION 07/2021 AND 08/2023. PHARMACY INFORMS US THAT WAS RETURNED TO US A PACKAGE OF OPENED BD ULTRA FINE PRO NEEDLES LOT 9141582 EXPIRATION 31.05.2024. THE CUSTOMER COMPLAINED THAT THERE ARE ALSO BD MICRO FINE 4MM NEEDLES IN THE PACKAGE. AFTER INSPECTION SEVERAL MICRO FINE NEEDLES WERE FOUND WITH EXPIRY DATE 07/2001 AS WELL AS 08/2023. THE CUSTOMER ASSURED NOT TO HAVE MIXED ANY BD PACKS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ PRO PEN NEEDLES HAD DIFFERING EXPIRATION DATES. THIS OCCURRED IN LOTS 9141582, 8205964, AND 6224650. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY INFORMS US THAT IN THE PEN NEEDLE PACKAGE, THERE WERE NEEDLES WITH EXPIRATION 07/2021 AND 08/2023. PHARMACY INFORMS US THAT WAS RETURNED TO US A PACKAGE OF OPENED BD ULTRA FINE PRO NEEDLES LOT 9141582 EXPIRATION 31.05.2024. THE CUSTOMER COMPLAINED THAT THERE ARE ALSO BD MICRO FINE 4MM NEEDLES IN THE PACKAGE. AFTER INSPECTION SEVERAL MICRO FINE NEEDLES WERE FOUND WITH EXPIRY DATE 07/2001 AS WELL AS 08/2023. THE CUSTOMER ASSURED NOT TO HAVE MIXED ANY BD PACKS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ PRO PEN NEEDLES HAD DIFFERING EXPIRATION DATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY INFORMS US THAT IN THE PEN NEEDLE PACKAGE, THERE WERE NEEDLES WITH EXPIRATION 07/2021 AND 08/2023. PHARMACY INFORMS US THAT WAS RETURNED TO US A PACKAGE OF OPENED BD ULTRA FINE PRO NEEDLES LOT 9141582 EXPIRATION 31.05.2024. THE CUSTOMER COMPLAINED THAT THERE ARE ALSO BD MICRO FINE 4MM NEEDLES IN THE PACKAGE. AFTER INSPECTION SEVERAL MICRO FINE NEEDLES WERE FOUND WITH EXPIRY DATE 07/2001 AS WELL AS 08/2023. THE CUSTOMER ASSURED NOT TO HAVE MIXED ANY BD PACKS.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579839 BD ULTRA-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown