BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 11008773 · Received December 15, 2020

    Report

    Report Number
    9616656-2020-01258
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (1) SEALED 4MM, 32G PEN NEEDLE FROM LOT # 9240206. CUSTOMER STATES THAT THERE WAS A SMALL LACK OF GLYCEMIC CONTROL DUE TO NOT HAVING DONE THE FULL INSULIN APPLICATION. THE RETURNED PEN NEEDLE WAS TESTED AND WAS ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PN 32G 4MM 5B XTW EASYFLOW LA WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMS THAT YESTERDAY (17/11) HE WAS APPLYING INSULIN AND WHEN INSERTING THE NEEDLE IN THE ABDOMEN AND TRYING TO PRESS THE PLUNGER OF THE PEN, IT STOPPED, MAKING IT IMPOSSIBLE TO COMPLETELY EJECT THE INSULIN. WHEN REMOVING THE NEEDLE FROM THE FABRIC, HE SAW A "RED DOT" AT THE TIP OF THE NEEDLE. HE SAW THIS RED DOT ONLY AFTER APPLICATION, BECAUSE WHEN REMOVING THE SEAL THE NEEDLE WAS NORMAL. WE QUESTIONED WHETHER IT WAS A POSSIBLE BLOOD DROPLET, HOWEVER THE PATIENT DID NOT KNOW FOR SURE. THE PATIENT MENTIONS THAT THERE WAS A SMALL LACK OF GLYCEMIC CONTROL DUE TO NOT HAVING DONE THE FULL INSULIN APPLICATION, BUT HE DID NOT GO TO THE DOCTOR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 32G 4MM 5B XTW EASYFLOW LA WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMS THAT YESTERDAY (17/11) HE WAS APPLYING INSULIN AND WHEN INSERTING THE NEEDLE IN THE ABDOMEN AND TRYING TO PRESS THE PLUNGER OF THE PEN, IT STOPPED, MAKING IT IMPOSSIBLE TO COMPLETELY EJECT THE INSULIN. WHEN REMOVING THE NEEDLE FROM THE FABRIC, HE SAW A "RED DOT" AT THE TIP OF THE NEEDLE. HE SAW THIS RED DOT ONLY AFTER APPLICATION, BECAUSE WHEN REMOVING THE SEAL THE NEEDLE WAS NORMAL. WE QUESTIONED WHETHER IT WAS A POSSIBLE BLOOD DROPLET, HOWEVER THE PATIENT DID NOT KNOW FOR SURE. THE PATIENT MENTIONS THAT THERE WAS A SMALL LACK OF GLYCEMIC CONTROL DUE TO NOT HAVING DONE THE FULL INSULIN APPLICATION, BUT HE DID NOT GO TO THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476902 PN 32G 4MM 5B XTW EASYFLOW LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 9240206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other