BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE

    MDR report key: 7363715 · Received March 22, 2018

    Report

    Report Number
    1213809-2018-00123
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 6, 2018
    Report Date
    April 4, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INITIAL REPORTER PHONE #: (B)(6). 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: THE INITIAL MDR REPORTED THE LOT # AS UNKNOWN. THE COMPLAINT REFERENCED 2 POSSIBLE LOT NUMBERS. LOT # EXPIRATION DATE AND MANUFACTURE DATE FOR EACH ARE AS FOLLOWS. LOT # : 6212774, EXPIRATION DATE: 07/31/2021, MANUFACTURE DATE: 08/02/2016. LOT # : 7060859, EXPIRATION DATE: 02/28/2022, MANUFACTURE DATE: 03/12/2017. INVESTIGATION SUMMARY: ONE LOOSE 5ML SYRINGE AND A PHOTO RECEIVED AT BD (B)(4) FROM UNKNOWN BATCH NUMBER (P/N 301027). SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE OBSERVED TO HAVE A DISTORTED STOPPER, A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. BASED ON THE SAMPLE AND PHOTO EVALUATION, PRODUCT DEFECT IS CONFIRMED. STOPPER JAMMED INSECURE/POSSIBLE LOT NUMBERS : (6212774 , 7060859). DHR REVIEW FOR BATCH 6212774 (P/N 301027): MANUFACTURING DATES: 08/02/2016 TO 08/03/2016. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6212774 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7060859 (P/N 301027): MANUFACTURING DATES: 03/12/2017 TO 03/13/2017. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7060859 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ROOT CAUSE AND CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER SEAL IN A BD PLASTIC NON-STERILE 5ML LUER-LOK¿ TIP SYRINGE WAS FOUND MISALIGNED PRIOR TO USE. THERE WAS NO EXPOSURE, INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203913 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other