BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7089629 · Received December 6, 2017

    Report

    Report Number
    1213809-2017-00364
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 13, 2017
    Report Date
    January 15, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MEDICAL DEVICE CATALOG # 302995.

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED (20) TWENTY SEALED 10ML PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM MULTIPLE BATCHES ¿ FIVE FROM EACH OF 7249910, 7249951, 7241901, 7212555 (P/N 302995). ALL 20 SAMPLES WERE VISUALLY EVALUATED. THE OILY SUBSTANCE OBSERVED ON THE BLACK STOPPER WAS IDENTIFIED AS SILICONE THAT IS USED IN THE MANUFACTURING PROCESS. THE AMOUNT OBSERVED WAS A NORMAL AND EXPECTED AMOUNT OF SILICONE FOR THIS PRODUCT. NO STRINGING AND NO POOLING OF SILICONE WAS OBSERVED. A SMALL AMOUNT OF SILICONE IS REQUIRED FOR THE PRODUCT TO FUNCTION PROPERLY. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. DHR REVIEW FOR BATCH 7249910 (P/N 302995): MANUFACTURING DATE: 09/25/2017. BATCH QUANTITY WAS 504,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7249910 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7249951 (P/N 302995): MANUFACTURING DATES: 09/23/2017 TO 09/24/2017. BATCH QUANTITY WAS 504,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7249951 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7241901 (P/N 302995): MANUFACTURING DATE: 09/09/2017. BATCH QUANTITY WAS 504,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7241901 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7212555 (P/N 302995): MANUFACTURING DATES: 08/17/2017. BATCH QUANTITY WAS 504,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7212555 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. UNABLE TO DETERMINE A ROOT CAUSE 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 #: 7249910, EXPIRATION DATE: 2022-08-31, MANUFACTURE DATE: 2017-09-06. MEDICAL DEVICE LOT #: 7249951, EXPIRATION DATE: 2022-08-31, MANUFACTURE DATE: 2017-09-06. MEDICAL DEVICE LOT #: 7241901, EXPIRATION DATE: 2022-08-31, MANUFACTURE DATE: 2017-08-29. MEDICAL DEVICE LOT #: 7212555, EXPIRATION DATE: 2022-07-31, MANUFACTURE DATE: 2017-07-31. 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 AN OILY SUBSTANCE WAS FOUND ON THE BLACK PLUNGER OF A BD SYRINGE LUER-LOK¿ TIP BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865425 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other