BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7059509 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00308
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 31, 2017
    Report Date
    February 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7212586. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2017-07-31. MEDICAL DEVICE LOT #: 7209876. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2017-07-28. MEDICAL DEVICE LOT #: 7236562. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2017-08-24. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR REVIEW FOR BATCH 7212586: MANUFACTURING DATES: 08/20/2017 TO 08/21/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7212586 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7209878: MANUFACTURING DATES: 08/13/2017 TO 08/14/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7209878 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7236562: MANUFACTURING DATE: 9/1/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7236562 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ELEVEN 10ML SAMPLES PACKAGED SYRINGES (SEVEN SEALED AND FOUR OPENED) CONFIRMED TO BE FROM BATCH # 7212586. FOUR 10ML PACKAGED SYRINGES (THREE SEALED AND ONE OPENED ) CONFIRMED TO BE FROM BATCH # 7209878. THREE OPEN 10ML PACKAGED SYRINGES CONFIRMED TO BE FROM BATCH # 7236562. SAMPLES WERE VISUALLY EVALUATED AND FIVE SYRINGES WERE FOUND TO HAVE EXCESSIVE SILICONE. ALL FIVE SYRINGES WERE FROM BATCH # 7212586. THE EXCESSIVE SILICONE OBSERVED IS A REJECTABLE CONDITION AT BD (B)(4). INVESTIGATION CONCLUSION: BASED ON SAMPLES, THE INVESTIGATION CONCLUDED: ¿CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE ADDITIONAL SAMPLES WERE ALSO RECEIVED (NOT BD (B)(4 PRODUCT-(B)(4) PRODUCT) BUT NO REPORT RECEIVED FROM CUSTOMER: ONE OPEN 10ML PACKAGED SYRINGE CONFIRMED TO BE FROM BATCH # 7107560. ONE OPEN 5ML PACKAGED SYRINGE CONFIRMED TO BE FROM BATCH # 7238673.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STICKY RESIDUE WAS FOUND IN THE BARREL OF A BD SYRINGE LUER-LOK¿ TIP. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839023 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other