BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11298933 · Received February 8, 2021

    Report

    Report Number
    9616656-2021-00138
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 18, 2021
    Report Date
    April 7, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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: 2021-03-18. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) SEALED 4MM, 32G PEN NEEDLES FROM LOT # 0077817. CUSTOMER STATES THAT THERE IS A WHITE SUBSTANCE ON THE NEEDLE. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON ANY OF THE SAMPLES. CUSTOMER RETURNED (3) SEALED 4MM, 32G PEN NEEDLES FROM LOT # 0133297. CUSTOMER STATES THAT THERE IS A WHITE SUBSTANCE ON THE NEEDLE. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON ANY OF THE SAMPLES. CUSTOMER RETURNED (3) SEALED 4MM, 32G PEN NEEDLES FROM LOT # 0119875. CUSTOMER STATES THAT THERE IS A WHITE SUBSTANCE ON THE NEEDLE. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON ANY OF THE SAMPLES. CUSTOMER RETURNED (3) SEALED 4MM, 32G PEN NEEDLES FROM LOT # 0106047. CUSTOMER STATES THAT THERE IS A WHITE SUBSTANCE ON THE NEEDLE. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON ANY OF THE SAMPLES. A LOT HISTORY REVIEW WAS CARRIED OUT ON LOTS 0133297, 0119875, 0106047, AND 0077817 AND THERE WERE NO RELATED NON CONFORMANCES RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX 1200 US HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS A WHITE SUBSTANCE ON THE NEEDLE. VERBATIM: FROM PHONE CALL ON 2021-01-25 21:25:37: PARENT OF YOUNG CHILD STATED, SHE IS SEEING A "WHITE SUBSTANCE" ON TIP OF NEEDLE. STATED, SHE ATTACHES THE PEN NEEDLE TO INSULIN PEN AND THEN NOTICES A SMALL "DOT OF LIQUID/WHITE SUBSTANCE. STATED, SHE IS AFRAID TO INJECT IT INTO HER SON. STATED, SHE PURCHASED 8 BOXES AND SHE TESTED A FEW NEEDLES FROM EACH BOX STATED, SHE PREFERS THE ORIGNAL NANO BUT IS NOW USING 2ND GEN LOT: 0133297 X 2. LOT: 0077817 X1. LOT: 0106047 X 2. LOT: 0119875 X 2. LOT: UNKNOWN EIGHT LOT'S IN TOTAL BUT ONE IS "UNKNOWN DATE OF EVENT: UNKNOWN. CATALOG: 320550. SAMPLES: YES. WILL CALL IN AFTER A FEW WEEKS FOR EVALUATION RESULTS. DOES NOT WANT TO CONTINUE USING BOXES. CL. INFORMATION FROM EMAIL COPIED AND PASTED BELOW: EMAIL RECEIVED¿2021-01-18 16:53:08SHE STATED THAT SHE HAS 8 BOXES OF MATERIAL NUMBER: 320550, LOT NUMBER: 0119875. ALL 8 BOXES HAVE A WHITE SUBSTANCE ON THE NEEDLE. SHE ALSO READ SOME REVIEWS ABOUT IT AND OTHER PARENTS MENTIONED THIS WHITE SUBSTANCES AS WELL, SO SHE IS WONDERING IF THIS IS NORMAL AND IT IS OKAY TO USE."

    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 #: 119875, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-28, MEDICAL DEVICE LOT #: 133297, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: 2020-05-12, MEDICAL DEVICE LOT #: 077817, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-03-17, MEDICAL DEVICE LOT #: 106047, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-15, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN, 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 NDL 32G 4MM HP 100 BOX 1200 US HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS A WHITE SUBSTANCE ON THE NEEDLE. VERBATIM: FROM PHONE CALL ON 2021-01-25 21:25:37: PARENT OF YOUNG CHILD STATED, SHE IS SEEING A "WHITE SUBSTANCE" ON TIP OF NEEDLE. STATED, SHE ATTACHES THE PEN NEEDLE TO INSULIN PEN AND THEN NOTICES A SMALL "DOT OF LIQUID/WHITE SUBSTANCE. STATED, SHE IS AFRAID TO INJECT IT INTO HER SON. STATED, SHE PURCHASED 8 BOXES AND SHE TESTED A FEW NEEDLES FROM EACH BOX STATED, SHE PREFERS THE ORIGNAL NANO BUT IS NOW USING 2ND GEN LOT: 0133297 X 2 LOT: 0077817 X1 LOT: 0106047 X 2 LOT: 0119875 X 2 LOT: UNKNOWN EIGHT LOT'S IN TOTAL BUT ONE IS "UNKNOWN DATE OF EVENT: UNKNOWN CATALOG: 320550 SAMPLES: YES WILL CALL IN AFTER A FEW WEEKS FOR EVALUATION RESULTS. DOES NOT WANT TO CONTINUE USING BOXES. INFORMATION FROM EMAIL COPIED AND PASTED BELOW: EMAIL RECEIVED: 2021-01-18 16:53:08 SHE STATED THAT SHE HAS 8 BOXES OF MATERIAL NUMBER: 320550, LOT NUMBER: 0119875. ALL 8 BOXES HAVE A WHITE SUBSTANCE ON THE NEEDLE. SHE ALSO READ SOME REVIEWS ABOUT IT AND OTHER PARENTS MENTIONED THIS WHITE SUBSTANCES AS WELL, SO SHE IS WONDERING IF THIS IS NORMAL AND IT IS OKAY TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189619 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H.10. 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1