BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 10892126 · Received November 24, 2020

    Report

    Report Number
    9616656-2020-01175
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 29, 2020
    Report Date
    April 14, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/12/2021. H.6. INVESTIGATION: FOUR OPEN AND SEVENTEEN SEALED 30G X 5MM SAFETY PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9149162, CAT. NO.329505. VISUAL EXAMINATION WAS CARRIED OUT ON THE FOUR OPEN SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE, NO ISSUES WERE OBSERVED ON THE REMAINING THREE OPEN SAMPLES. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON THE SEVENTEEN SEALED SAMPLES AND NO ISSUES WERE OBSERVED. 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. AS THE CONFIRMED SAMPLE WAS RETURNED OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10.

    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 REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30GX5MM WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE NEEDLE WAS BENT AND WOULD NOT WORK. DEAR SIR/MADAM I WISH TO RAISE A COMPLAINT REGARDING THE ABOVE SYRINGES, LOT 9141962 2022-06. I USE THESE FOR MY INSULIN. UNFORTUNATELY, THERE WAS A SIGNIFICANT NUMBER OF MY BOX, WHERE THE NEEDLE WAS BENT AND WOULD NOT WORK. I WOULD SAY ABOUT 18 TO 22 PERCENT OF THE PRODUCT HAD TO BE THROWN OUT, MEANING THAT TWO OR MORE WERE USED IN EACH APPLICATION. CLEARLY, THIS WAS A PROCESS ISSUE IN PRODUCTION, OR A FAILURE TO DETECT THE DEFECTS, PRIOR TO DISTRIBUTION. WE HAVE NEVER HAD THIS MANY FAILURES, HENCEFORTH I AM LETTING YOU KNOW THAT THE QUALITY OF YOUR PRODUCT MUST BE MAINTAINED IN BETTER WAYS THAN IT HAS BEEN SUPPLIED ON THIS OCCASION. I DID NOT SAVE THE DEFECTIVE NEEDLES, AS THERE IS NO WAY YOU CAN TELL UNTIL YOU REMOVE THE SEAL. WHAT I DO KNOW IS THAT PEOPLE WITH MEDICAL CONDITIONS CANNOT AFFORD CONTINUAL REPLACEMENTS IF THE PRODUCT ARRIVES IN UNWORKABLE CONDITION. PLEASE DISTRIBUTE VIA QUALITY CONTROL, AS THIS NEEDS TO BE ADDRESSED. THANKING YOU. (B)(6) 2020 UPDATE: THERE WERE TWO (2) ISSUES. FIRST WAS BENT NEEDLE ENDS IN UNWRAPPING THE NEEDLE COVER. SECOND ONE WAS SOME NEEDLES WERE NOT HOLLOW AND INSULIN COULD NOT BE PUSHED THROUGH THEM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30GX5MM WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE NEEDLE WAS BENT AND WOULD NOT WORK DEAR SIR/MADAM I WISH TO RAISE A COMPLAINT REGARDING THE ABOVE SYRINGES, LOT 9141962 2022-06. I USE THESE FOR MY INSULIN. UNFORTUNATELY, THERE WAS A SIGNIFICANT NUMBER OF MY BOX, WHERE THE NEEDLE WAS BENT AND WOULD NOT WORK. I WOULD SAY ABOUT 18 TO 22 PERCENT OF THE PRODUCT HAD TO BE THROWN OUT, MEANING THAT TWO OR MORE WERE USED IN EACH APPLICATION. CLEARLY, THIS WAS A PROCESS ISSUE IN PRODUCTION, OR A FAILURE TO DETECT THE DEFECTS, PRIOR TO DISTRIBUTION. WE HAVE NEVER HAD THIS MANY FAILURES, HENCEFORTH I AM LETTING YOU KNOW THAT THE QUALITY OF YOUR PRODUCT MUST BE MAINTAINED IN BETTER WAYS THAN IT HAS BEEN SUPPLIED ON THIS OCCASION. I DID NOT SAVE THE DEFECTIVE NEEDLES, AS THERE IS NO WAY YOU CAN TELL UNTIL YOU REMOVE THE SEAL. WHAT I DO KNOW IS THAT PEOPLE WITH MEDICAL CONDITIONS CANNOT AFFORD CONTINUAL REPLACEMENTS IF THE PRODUCT ARRIVES IN UNWORKABLE CONDITION. PLEASE DISTRIBUTE VIA QUALITY CONTROL, AS THIS NEEDS TO BE ADDRESSED. THANKING YOU 03 NOV 2020 UPDATE: THERE WERE TWO (2) ISSUES. FIRST WAS BENT NEEDLE ENDS IN UNWRAPPING THE NEEDLE COVER. SECOND ONE WAS SOME NEEDLES WERE NOT HOLLOW AND INSULIN COULD NOT BE PUSHED THROUGH THEM."

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30GX5MM WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE NEEDLE WAS BENT AND WOULD NOT WORK DEAR SIR/MADAM I WISH TO RAISE A COMPLAINT REGARDING THE ABOVE SYRINGES, LOT 9141962 2022-06. I USE THESE FOR MY INSULIN. UNFORTUNATELY, THERE WAS A SIGNIFICANT NUMBER OF MY BOX, WHERE THE NEEDLE WAS BENT AND WOULD NOT WORK. I WOULD SAY ABOUT 18 TO 22 PERCENT OF THE PRODUCT HAD TO BE THROWN OUT, MEANING THAT TWO OR MORE WERE USED IN EACH APPLICATION. CLEARLY, THIS WAS A PROCESS ISSUE IN PRODUCTION, OR A FAILURE TO DETECT THE DEFECTS, PRIOR TO DISTRIBUTION. WE HAVE NEVER HAD THIS MANY FAILURES, HENCEFORTH I AM LETTING YOU KNOW THAT THE QUALITY OF YOUR PRODUCT MUST BE MAINTAINED IN BETTER WAYS THAN IT HAS BEEN SUPPLIED ON THIS OCCASION. I DID NOT SAVE THE DEFECTIVE NEEDLES, AS THERE IS NO WAY YOU CAN TELL UNTIL YOU REMOVE THE SEAL. WHAT I DO KNOW IS THAT PEOPLE WITH MEDICAL CONDITIONS CANNOT AFFORD CONTINUAL REPLACEMENTS IF THE PRODUCT ARRIVES IN UNWORKABLE CONDITION. PLEASE DISTRIBUTE VIA QUALITY CONTROL, AS THIS NEEDS TO BE ADDRESSED. THANKING YOU 03 NOV 2020 UPDATE: THERE WERE TWO (2) ISSUES. FIRST WAS BENT NEEDLE ENDS IN UNWRAPPING THE NEEDLE COVER. SECOND ONE WAS SOME NEEDLES WERE NOT HOLLOW AND INSULIN COULD NOT BE PUSHED THROUGH THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356864 PEN NEEDLE AUTOSHIELD DUO 30GX5MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9141962

    Patients

    Seq Age Sex Outcome Treatment
    1