BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE

    MDR report key: 13290932 · Received January 19, 2022

    Report

    Report Number
    8041187-2022-00015
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    December 24, 2021
    Report Date
    February 25, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057826
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1147619 MEDICAL DEVICE EXPIRATION DATE: 05/31/2026 DEVICE MANUFACTURE DATE: 05/27/2021 MEDICAL DEVICE LOT #: 1084899. MEDICAL DEVICE EXPIRATION DATE: 03/31/2026. DEVICE MANUFACTURE DATE: 03/25/2021. MEDICAL DEVICE LOT #: 1204165. MEDICAL DEVICE EXPIRATION DATE: 07/31/2026. DEVICE MANUFACTURE DATE: 07/23/2021. MEDICAL DEVICE LOT #: 0300498. MEDICAL DEVICE EXPIRATION DATE: 10/31/2025. DEVICE MANUFACTURE DATE: 10/26/2020. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (SYRINGE). PMA / 510(K)#: K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1147619 MEDICAL DEVICE EXPIRATION DATE: 05/31/2026 DEVICE MANUFACTURE DATE: 05/27/2021 MEDICAL DEVICE LOT #: 1084899. MEDICAL DEVICE EXPIRATION DATE: 03/31/2026. DEVICE MANUFACTURE DATE: 03/25/2021. MEDICAL DEVICE LOT #: 1204165. MEDICAL DEVICE EXPIRATION DATE: 07/31/2026. DEVICE MANUFACTURE DATE: 07/23/2021. MEDICAL DEVICE LOT #: 0300498. MEDICAL DEVICE EXPIRATION DATE: 10/31/2025. DEVICE MANUFACTURE DATE: 10/26/2020. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (SYRINGE). PMA / 510(K)#: K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/14/2022. H.6. INVESTIGATION: FIFTY-SIX (56) SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. ONE SAMPLE IN SEALED PACKAGING WAS RECEIVED FOR BATCH 0300498, THREE SAMPLES IN SEALED PACKAGING FOR 1084899, TWO SAMPLES IN SEALED PACKAGING FOR 1204165, AND FORTY-SEVEN (47) IN SEALED PACKAGING AND THREE SAMPLES WITH OPEN PACKAGING FOR BATCH 1147619. ALL SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. ELEVEN OF THE RETURNED SAMPLES WERE OBSERVED WITH SLIGHT SKEWED SCALE MARKING, ONE SAMPLE FROM BATCH 0300498, THREE SAMPLES FROM BATCH 1084899, TWO SAMPLES FROM BATCH 1204165, AND FIVE SAMPLES FROM BATCH 1147619. ALL ELEVEN SAMPLES IDENTIFIED WITH SKEWED SCALE MARKING WERE SUBJECTED TO VOLUMETRIC TESTING AND PASSED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. ALTHOUGH THERE IS A SLIGHT SKEW IN THE SCALE MARKING, IT DOES NOT AFFECT THE DOSAGE OF THE SOLUTION AS THE VOLUMETRIC TEST IS WITHIN SPECIFICATION. AN INVESTIGATION WAS CONDUCTED AT THE SYRINGE APEX PRINTING MACHINE TO FIND THE CAUSE OF THE SKEWED PRINTING. THE PRINTING PAD SET UP PLAYS AN IMPORTANT ROLE TO ACHIEVE GOOD PRINTING ON THE BARREL. WITH A GOOD PRINTING PAD SET UP, CONSISTENT PRINTING IS ACHIEVED AS THE PRINTING PAD IS SECURED ON THE PRINTING DRUM. IT WAS UNDERSTOOD THAT ANY SLIGHT SKEWED PRINTING WAS DEEMED ACCEPTABLE DURING ROUTINE INSPECTION AS THIS DEFECT DOES NOT AFFECT THE VOLUMETRIC TEST. THEREFORE, THE ROOT CAUSE IS ATTRIBUTED TO THE INATTENTIVENESS OF THE SLIGHT SKEWED PRINTING DEFECT BY THE PRODUCTION TECHNICIAN DURING PRINTING PAD SET-UP AND BY BOTH THE MANUFACTURING AND QUALITY ASSURANCE ASSOCIATE DURING ROUTINE INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES ON THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THIS EVENT OCCURRED 56 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE SCALE IS SKEWED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES ON THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THIS EVENT OCCURRED 56 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE SCALE IS SKEWED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES ON THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THIS EVENT OCCURRED 56 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE SCALE IS SKEWED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737929 BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305782 SEE H.10. 30382903057826

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown