BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISION GLIDE NEEDLE 26G 1/2IN BROWN

    MDR report key: 13261713 · Received January 14, 2022

    Report

    Report Number
    8041187-2021-01120
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 22, 2021
    Report Date
    February 4, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 6265182; D4: MEDICAL DEVICE EXPIRATION DATE: 2021-09-30; H4: DEVICE MANUFACTURE DATE: 2016-09-21. D4: MEDICAL DEVICE LOT #: 6265185; D4: MEDICAL DEVICE EXPIRATION DATE: 2021-09-30; H4: DEVICE MANUFACTURE DATE: 2016-09-21. D4: MEDICAL DEVICE LOT #: 7200446; D4: MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; H4: DEVICE MANUFACTURE DATE: 2017-07-19. D4: MEDICAL DEVICE LOT #: 7264360; D4: MEDICAL DEVICE EXPIRATION DATE: 2022-09-30; H4: DEVICE MANUFACTURE DATE: 2017-09-21. D4: MEDICAL DEVICE LOT #: 8263279; D4: MEDICAL DEVICE EXPIRATION DATE: 2023-09-30; H4: DEVICE MANUFACTURE DATE: 2018-09-20. D4: MEDICAL DEVICE LOT #: 8292408; D4: MEDICAL DEVICE EXPIRATION DATE: 2023-10-31; H4: DEVICE MANUFACTURE DATE: 2018-10-19. D4: MEDICAL DEVICE LOT #: 9108830; D4: MEDICAL DEVICE EXPIRATION DATE: 2024-04-30; H4: DEVICE MANUFACTURE DATE: 2019-04-18. D4: MEDICAL DEVICE LOT #: 0083106; D4: MEDICAL DEVICE EXPIRATION DATE: 2025-03-31; H4: DEVICE MANUFACTURE DATE: 2020-03-23. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-28. H6: INVESTIGATION SUMMARY SEVENTY-THREE SAMPLES, 1 SAMPLE FROM BATCH 6265182, 5 SAMPLES FROM 6265185, 1 SAMPLE FROM BATCH 7200446, 25 SAMPLES FROM BATCH 7264360, 16 SAMPLES FROM BATCH 8263279, 1 SAMPLE FROM BATCH 8292408, 2 SAMPLE FROM BATCH 8239044, 21 SAMPLES FROM BATCH 9108830, AND 1 SAMPLE FROM BATCH 0083106, WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. ALL SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND FAINT AND ILLEGIBLE EXPIRY DATE ON THE UNIT PACKAGE WAS OBSERVED FOR ALL SAMPLES. FOR BATCH 6265182, THE EXPIRY DATE FOR THE 1 SAMPLE IS NOT READABLE, FOR BATCH 6265185, THE EXPIRY DATE FOR 4 OUT OF 5 SAMPLES IS NOT READABLE, FOR BATCH 7200446, THE EXPIRY DATE FOR THE 1 SAMPLE IS READABLE, FOR BATCH 7264360, THE EXPIRY DATE FOR ALL 1 OUT OF 25 SAMPLES IS NOT READABLE, FOR BATCH 8263279, THE EXPIRY DATE FOR 1 OUT OF 16 SAMPLES IS NOT READABLE, FOR BATCH 8239044, THE EXPIRY DATE FOR THE 2 SAMPLES ARE READABLE, FOR BATCH 8292408, THE EXPIRY DATE FOR THE 1 SAMPLE IS READABLE, FOR BATCH 9108830, THE EXPIRY DATE FOR AL THE 21 SAMPLES ARE READABLE, AND FOR BATCH 0083106, THE EXPIRY DATE FOR THE 1 SAMPLE IS READABLE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. ONE POTENTIAL CAUSE OF FAINT OR ILLEGIBLE PRINT WOULD BE DUE TO THE INK ROLLER BEING OUT OF INK DUE TO A LONG PRODUCTION RUN IF THE INK IS NOT REPLACED OVER TIME. HOWEVER, THIS MAY NOT BE THE TRUE ROOT CAUSE AS THERE IS A 3 HOURLY OUTGOING INSPECTION AND 1 HOURLY IN-PROCESS INSPECTION IN PLACE TO CHECK FOR ILLEGIBLE PRINTING ON THE UNIT PACKAGE AND THERE WERE ALSO NO OBSERVATIONS OR QUALITY NOTIFICATION REPORTED ON ABY OF THE REPORTED LOTS. THE NEEDLE MULTIVAC PRODUCT / LOT CHANGEOVER CHECKLIST WAS IMPROVED IN OCTOBER 2019 TO INCLUDE CHECKING THE INK ROLLER CONDITION DURING CHANGEOVER AND REPLACE IF NECESSARY. BATCHES 6265182, 6265185, 7200446, 7264360, 8263279, 829408, 8239044, AND 9108830 WERE PRODUCED BEFORE THE ACTION IMPLEMENTATION. FOR BATCH 0083106, ONLY 1 UNIT PACKAGE FROM SUPPOSEDLY A STRIP OF 5-UNIT PACKAGE WAS RETURNED. BASED ON THE SAMPLE EVALUATION, THE EXPIRY DATE WAS READABLE WITH THE NAKED EYE EVEN THOUGH THE INK APPEARED TO BE LIGHT. AWARENESS TRAINING WILL BE CONDUCTED WITH THE PRODUCTION TECHNICIANS ON THIS COMPLAINT AND TO PERFORM DILIGENT INSPECTION FOR ILLEGIBLE PRINT ON THE UNIT PACKAGE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD PRECISION GLIDE NEEDLE 26G 1/2IN BROWN HAD A SMEARED LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CLINICIAN WAS UNABLE TO READ THE EXPIRY DATE AS THE WRITING WAS FADED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD PRECISION GLIDE NEEDLE 26G 1/2IN BROWN HAD A SMEARED LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CLINICIAN WAS UNABLE TO READ THE EXPIRY DATE AS THE WRITING WAS FADED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859525 BD PRECISION GLIDE NEEDLE 26G 1/2IN BROWN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown