BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE LUER-LOK¿

    MDR report key: 7104646 · Received December 11, 2017

    Report

    Report Number
    1213809-2017-00354
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 10, 2017
    Report Date
    March 19, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THREE PHOTOS WERE RECEIVED BY BD CANAAN DEPICTING A SINGLE PACKAGED 3ML SYRINGE CONFIRMED TO BE FROM BATCH #7120874 (P/N 309658). THE SYRINGE APPEARS TO HAVE SLIGHT STOPPER ANGULARITY VISIBLE. THE STOPPER ANGULARITY APPEARS TO BE MINOR AND WITHIN PRODUCT SPECIFICATION. PHYSICAL SAMPLE IS REQUIRED TO BE CONFIRMED WITH AN ACTUAL MEASUREMENT. A DEVICE HISTORY REVIEW (DHR) REVIEW FOR BATCH 7120874 (P/N 309658) WAS PERFORMED, ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7120874 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SINCE NO PHYSICAL EVIDENCE WAS FOUND TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES, A ROOT CAUSE COULD NOT BE DETERMINED. PROPER PERSONNEL HAVE BEEN NOTIFIED OF THIS ISSUE FOR FURTHER REVIEW. BASED ON THE FACT THAT NO REJECTABLE DEFECT WAS FOUND, CAPA IS NOT REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SAMPLE EVALUATION: TWO SEALED 3ML PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #7212683 AND 7120874 (P/N 309658) THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE MINOR STOPPER ANGULARITY. THE ANGULARITY OBSERVED IS AN ACCEPTABLE CONDITION AT BD (B)(4) AND IS CONSIDERED TO BE A COSMETIC DEFECT. THE SYRINGE FROM BATCH 7120874 ALSO HAD A BROKEN THUMB REST. THE THUMB REST OF THE PLUNGER ROD WAS DETACHED AND FOUND LOOSE IN THE SYRINGE PACKAGE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD (B)(4) WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. NO REJECTABLE DEFECTS CONFIRMED. BASED ON THE FACT THAT NO REJECTABLE DEFECT WAS FOUND, CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A BD PLASTIPAK¿ SYRINGE LUER-LOK¿ WERE FOUND TO BE ¿IMPOSSIBLE TO CHECK WITH CERTAINTY THE DESIRED VOLUME MEASUREMENTS.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885880 BD PLASTIPAK¿ SYRINGE LUER-LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7120874 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other