BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE AND NEEDLE COMBINATION LUER-LOK¿¿ TIP

    MDR report key: 7374184 · Received March 27, 2018

    Report

    Report Number
    1213809-2018-00175
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 13, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096343
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: TOTAL 207 SAMPLES WERE RECEIVED FROM 7 BATCHES. 2 SEALED 5ML 22G LUER-LOK SYRINGES CONFIRMED TO BE FROM BATCH #7193596 (P/N 309631). 2 SEALED AND 1 OPENED EMPTY PACKAGE OF 5ML 20G LUER-LOK SYRINGES CONFIRMED TO BE FROM BATCH #6307994 (P/N 309634). 1 SEALED 5ML 20G LUER-LOK SYRINGE CONFIRMED TO BE FROM BATCH #7002757 (P/N 309634). 23 SEALED AND 1 OPENED EMPTY PACKAGE OF 5ML 20G LUER-LOK SYRINGES CONFIRMED TO BE FROM BATCH# 8010589 ( P/N 309634). 11 SEALED OF 5ML 20G LUER-LOK SYRINGE CONFIRMED TO BE FROM BATCH# 7310985 (P/N 309634). 83 SEALED 5ML 20G LUER-LOK SYRINGES CONFIRMED TO BE FROM BATCH# 7338665 (P/N309634). 76 SEALED, 1 OPENED AND 1 OPENED EMPTY PACKAGE 5ML 20G LUER-LOK SYRINGES CONFIRMED TO BE FROM BATCH# 8010590 (P/N 309634). 5 LOOSE 5ML SYRINGES FROM UNKNOWN BATCH# AND P/N. SAMPLES WERE VISUALLY EVALUATED. 30 SYRINGES WERE RANDOMLY SELECTED FOR CLOSER EVALUATION. THEIR PACKAGES WERE OPENED AND SAMPLES EVALUATED. A SMALL AMOUNT OF SILICONE WAS OBSERVED ON THE STOPPER IN THE SAMPLES. THE AMOUNT OF SILICONE OBSERVED WAS A NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. ONE PACKAGE FROM BATCH 7338665 HAD A SMALL UNIDENTIFIED BLACK FLAKE FM LOOSE IN THE PACKAGE ON THE OUTSIDE OF THE NEEDLE SHIELD, IT WAS LESS THAN LEVEL 3 IN SIZE WHICH IS ACCEPTABLE CONDITION PER SPECIFICATION. NO DEFECTS WERE CONFIRMED DURING EVALUATION. DHR REVIEW FOR BATCH 7002757 (P/N 309634): MANUFACTURING DATES: 02/10/2017 TO 02/11/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7002757 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7338665 (P/N 309634): MANUFACTURING DATES: 12/09/2017 TO 12/10/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7338665WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 6307994 (P/N 309634): MANUFACTURING DATES: 12/04/2016 TO 12/05/2016. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6307994 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 8010589 (P/N 309634): MANUFACTURING DATE: 01/12/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8010589 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: ROOT CAUSE AND CAPA NOT REQUIRED AS NO DEFECTS WERE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7002757. MEDICAL DEVICE EXPIRATION DATE: 12/31/2021. DEVICE MANUFACTURE DATE: 01/02/2017. MEDICAL DEVICE LOT #: 7338665. MEDICAL DEVICE EXPIRATION DATE: 11/30/2022. DEVICE MANUFACTURE DATE: 12/04/2017. MEDICAL DEVICE LOT #: 6307994. MEDICAL DEVICE EXPIRATION DATE: 10/31/2021. DEVICE MANUFACTURE DATE: 11/02/2016. MEDICAL DEVICE LOT #: 8010589. MEDICAL DEVICE EXPIRATION DATE: 12/31/2022. DEVICE MANUFACTURE DATE: 01/10/2018. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE AND NEEDLE COMBINATION LUER-LOK¿ TIP HAD MOISTURE AND BLACK FLAKES WITHIN THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215907 BD SYRINGE AND NEEDLE COMBINATION LUER-LOK¿¿ TIP HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 00382903096343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other