BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 32G X 4MM 3B TW

    MDR report key: 11956875 · Received June 8, 2021

    Report

    Report Number
    3014704491-2021-00019
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TWO UNOPENED PEN NEEDLES WITH TEAR DROP LABELS IDENTIFYING THEM AS 4MM, 32 GAUGE PEN NEEDLES FROM LOT 0140356. THE SAMPLES WERE INSPECTED TO ENSURE THAT USING THEM WAS AS LEAST HARMFUL AS INTENDED. THE OUTER DIAMETERS OF THESE NEEDLES WERE MEASURED TO BE 0.0093 IN AND 0.0092 IN. BOTH NEEDLES WERE MEASURED WITHIN ACCEPTABLE OUTER DIAMETERS FOR 32 GAUGE NEEDLES (0.0090 IN TO 0.0095 IN). THE INTEGRITY OF EACH NEEDLE POINT WAS INSPECTED AND NO DEFECTS WERE FOUND. NO DEBRIS WAS FOUND AT THE TIP OF EITHER OF THE NEEDLES. LASTLY, FLOUR WAS APPLIED TO THE NEEDLES¿ CANNULAS TO ENSURE THAT LUBRICANT WAS PRESENT. SUFFICIENT LUBRICANT WAS FOUND ON ALL SAMPLES. NO DAMAGE TO THE NEEDLES OF ANY KIND WAS OBSERVED. THE NEEDLES WERE WITHIN SPECIFICATIONS AND DID NOT FEATURE ANY DULLNESS OR BURRS. ADDITIONALLY, THESE PEN NEEDLES WOULD SNAP INTO PLACE UPON TIGHTENING THEM ONTO A PEN. DHR WAS REVIEWED FOR LOT# 0140356 AND NO QN FOUND. DHR FILE CONTAINS: 1. PEN NEEDLE ASSEMBLY MANUFACTURE RECORD. 2. PEN NEEDLE ASSEMBLY INSPECTION RECORD. 3. PEN NEEDLE OUT-GOING INSPECTION RECORD. BASED ON THE SAMPLES RECEIVED, BD WAS NOT ABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DULL NEEDLES. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PN RELION 32G X 4MM 3B TW EXPERIENCED DIFFICULT OPERATION OR WAS NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320618 BATCH NO: 0140356. RELION REPORTED, NEEDLES ARE DULLSTATED, THEY DON'T "SNAP" ON LIKE BEFORE, (EXPLAINED TO CONSUMER THE DESIGN WAS CHANGED, SHE NOW HAS TO TWIST THE PEN NEEDLE TO ATTACH). STATED, HAD DIFFICULTY ATTACHING PEN NEEDLES TO PEN.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PN RELION 32G X 4MM 3B TW EXPERIENCED DIFFICULT OPERATION OR WAS NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320618 BATCH, NO: 0140356. RELION REPORTED, NEEDLES ARE DULLSTATED, THEY DON'T "SNAP" ON LIKE BEFORE, (EXPLAINED TO CONSUMER THE DESIGN WAS CHANGED, SHE NOW HAS TO TWIST THE PEN NEEDLE TO ATTACH). STATED, HAD DIFFICULTY ATTACHING PEN NEEDLES TO PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854219 PN RELION 32G X 4MM 3B TW PEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140356

    Patients

    Seq Age Sex Outcome Treatment
    1