BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 11305480 · Received February 9, 2021

    Report

    Report Number
    9616656-2021-00148
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 20, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-21. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (44) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL OR INNER SHIELD. CUSTOMER STATES THAT THERE WAS A LACK OF GLYCEMIC CONTROL DUE TO THE NEEDLES BEING CLOGGED. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 15 OUT OF 44 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM PROPERLY FLOWING THROUGH THE CANNULA. ALL REMAINING SAMPLES WERE TESTED AND ALL WERE 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. ROOT CAUSE IS USER RELATED. THE NON PATIENT END OF THE CANNULA WAS BENT DURING USE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 55 PN 32G 4MM 5B XTW EASYFLOW LA WERE DIFFICULT TO PRIME DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PATIENT GOT IN TOUCH TO REPORT A POSSIBLE QUALITY DEVIATION IN THE BD ULTRA-FINE 4MM NEEDLES (LOT: 0106044 MANUFACTURED: 05/2020 VALIDITY: 04/2025 AND LOT: 9240206 MANUFACTURED: 09/2019 VALIDITY: 08/2024) CUSTOMER INFORMS THAT IT USES BD ULTRA-FINE NEEDLES FOR INSULIN APPLICATION (SANOFI) AND IN THE LAST TWO LOTS PURCHASED, SOME NEEDLES WERE CLOGGED. SHE REPORTS THAT SHE NOTICED THE DEVIATION AS SOON AS SHE PERFORMED THE FLOW TEST AND THERE WAS NO EJECTION OF THE LIQUID. IN THE FIRST BATCH, AROUND 30 NEEDLES CAUSED THE PROBLEM. IN THE SECOND BATCH, THERE WERE AROUND 25. THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2020. THE PATIENT REPORTED THAT ON ONE OCCASION THERE WAS A LACK OF GLYCEMIC CONTROL DUE TO THE NEEDLES BEING CLOGGED, HOWEVER SHE DID NOT HAVE TO GO TO THE HOSPITAL, BUT SHE CONTACTED HER DOCTOR TO INVESTIGATE THE SITUATION. IT IS NOT REUSED. ADDITIONAL INFORMATION: DOCTOR PRESCRIBED A HIGHER DOSAGE OF INSULIN."

    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 #: 0106044, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-15, MEDICAL DEVICE LOT #: 9240206, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-28. 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 55 PN 32G 4MM 5B XTW EASYFLOW LA WERE DIFFICULT TO PRIME DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PATIENT GOT IN TOUCH TO REPORT A POSSIBLE QUALITY DEVIATION IN THE BD ULTRA-FINE 4MM NEEDLES (LOT: 0106044 MANUFACTURED: 05/2020 VALIDITY: 04/2025 AND LOT: 9240206 MANUFACTURED: 09/2019 VALIDITY: 08/2024) CUSTOMER INFORMS THAT IT USES BD ULTRA-FINE NEEDLES FOR INSULIN APPLICATION (SANOFI) AND IN THE LAST TWO LOTS PURCHASED, SOME NEEDLES WERE CLOGGED. SHE REPORTS THAT SHE NOTICED THE DEVIATION AS SOON AS SHE PERFORMED THE FLOW TEST AND THERE WAS NO EJECTION OF THE LIQUID. IN THE FIRST BATCH, AROUND 30 NEEDLES CAUSED THE PROBLEM. IN THE SECOND BATCH, THERE WERE AROUND 25. THIS PROBLEM HAS BEEN OCCURRING SINCE JULY / 2020. THE PATIENT REPORTED THAT ON ONE OCCASION THERE WAS A LACK OF GLYCEMIC CONTROL DUE TO THE NEEDLES BEING CLOGGED, HOWEVER SHE DID NOT HAVE TO GO TO THE HOSPITAL, BUT SHE CONTACTED HER DOCTOR TO INVESTIGATE THE SITUATION. IT IS NOT REUSED. ADDITIONAL INFORMATION: DOCTOR PRESCRIBED A HIGHER DOSAGE OF INSULIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201428 PN 32G 4MM 5B XTW EASYFLOW LA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR