BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 10486290 · Received September 2, 2020

    Report

    Report Number
    9616656-2020-00882
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    July 29, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PN 32G 4MM 5B XTW EASYFLOW LA WAS NOT WORKING PROPERLY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT HE BOUGHT TWO BOXES OF NEEDLES AND THAT HE IS UNABLE TO USE THEM BECAUSE THE NEEDLES ARE BENDING AT THE JUNCTION. INFO RECEIVED: CUSTOMER INFORMED THAT HIS MOTHER AND HE HAVE BEEN USING BD ULTRA FINE 4MM NEEDLES FOR A LONG TIME AND THAT IN THE LAST TWO LOTS PURCHASED MORE THAN HALF OF THE BOX CAME DEFECTIVE, HE MENTIONS THAT WHEN TRYING TO INSERT THE NEEDLE INTO THE SKIN, A LOT OF DIFFICULTY AND THE NEEDLE ENDS UP BENDING AT THE TIP CAUSING PAIN AND MAKING IT IMPOSSIBLE TO USE. HE SAID HE HAS BEEN USING THE SAME NEEDLE FOR THREE DAYS BECAUSE HE FOUND AT LEAST ONE GOOD ONE AMONG THE BAD ONES AND IS AFRAID TO STOP USING IT AND PICK ONE THAT HURTS AND BENDS AGAIN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8227644, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2018-08-15. MEDICAL DEVICE LOT #: 9240206, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-28. INITIAL REPORTER PHONE#: (B)(6). DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6)2020. AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON 2020-08-31 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PN 32 G 4 MM 5 B XTW EASYFLOW LA WAS NOT WORKING PROPERLY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT HE BOUGHT TWO BOXES OF NEEDLES AND THAT HE IS UNABLE TO USE THEM BECAUSE THE NEEDLES ARE BENDING AT THE JUNCTION. INFO RECEIVED: CUSTOMER INFORMED THAT HIS MOTHER AND HE HAVE BEEN USING BD ULTRA FINE 4 MM NEEDLES FOR A LONG TIME AND THAT IN THE LAST TWO LOTS PURCHASED MORE THAN HALF OF THE BOX CAME DEFECTIVE, HE MENTIONS THAT WHEN TRYING TO INSERT THE NEEDLE INTO THE SKIN, A LOT OF DIFFICULTY AND THE NEEDLE ENDS UP BENDING AT THE TIP CAUSING PAIN AND MAKING IT IMPOSSIBLE TO USE. HE SAID HE HAS BEEN USING THE SAME NEEDLE FOR THREE DAYS BECAUSE HE FOUND AT LEAST ONE GOOD ONE AMONG THE BAD ONES AND IS AFRAID TO STOP USING IT AND PICK ONE THAT HURTS AND BENDS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949974 PN 32G 4MM 5B XTW EASYFLOW LA PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other