BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 10106575 · Received June 1, 2020

    Report

    Report Number
    1213809-2020-00347
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 12, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 8307660. D4. MEDICAL DEVICE EXPIRATION DATE: 10/31/2023. H4. DEVICE MANUFACTURE DATE: 11/3/2018. D4. MEDICAL DEVICE LOT #: 0006918. D4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2024. H4. DEVICE MANUFACTURE DATE: 1/6/2020. D4. MEDICAL DEVICE LOT #: 9001511. D4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023. H4. DEVICE MANUFACTURE DATE: 1/1/2019. D4. MEDICAL DEVICE LOT #: 9163897. D4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2024. H4. DEVICE MANUFACTURE DATE: 6/12/2019. D4. MEDICAL DEVICE LOT #: 9246782. D4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2024. H4. DEVICE MANUFACTURE DATE: 9/3/2019. D10. DEVICE AVAILABLE FOR EVAL?: YES. D10. RETURNED TO MANUFACTURER ON: 6/10/2020. H6. INVESTIGATION: THIRTEEN 5ML SYRINGES IN FULLY SEALED BLISTER PACKS WERE RECEIVED AND EVALUATED. THREE WERE FROM BATCH 8307660, TWO WERE FROM BATCH 0006918, THREE WERE FROM BATCH 9001511, THREE WERE FROM BATCH 9163897, AND TWO WERE FROM BATCH 9246782. IT APPEARED THE "OILY RESIDUE" WAS SILICONE WITH ALL THE SAMPLES CONTAINING THE NORMAL AND EXPECTED AMOUNT PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PLEASE NOTE THAT 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXCESS LUBRICANT WAS FOUND ON THE BD SYRINGE LUER-LOK¿ TIP'S PLUNGER BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE NOTICED THAT THE BLACK TIP OF THE PLUNGER ON SOME OF THE STERILE 5ML AND 10ML SYRINGES APPEAR TO HAVE AN EXCESS RESIDUE COVERING THEM. THIS IS OILY IN APPEARANCE. THE CURRENT BATCH NUMBERS FOR THE 10ML SYRINGES WHICH WE HAVE IN STOCK ARE AS FOLLOWS: 1911008, 2001006. WE USE THE SYRINGES TO PREPARE STERILE PRODUCTS IN OUR MANUFACTURING UNITS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXCESS LUBRICANT WAS FOUND ON THE BD SYRINGE LUER-LOK¿ TIP'S PLUNGER BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE NOTICED THAT THE BLACK TIP OF THE PLUNGER ON SOME OF THE STERILE 5ML AND 10ML SYRINGES APPEAR TO HAVE AN EXCESS RESIDUE COVERING THEM. THIS IS OILY IN APPEARANCE. THE CURRENT BATCH NUMBERS FOR THE 10ML SYRINGES WHICH WE HAVE IN STOCK ARE AS FOLLOWS: 1911008, 2001006. WE USE THE SYRINGES TO PREPARE STERILE PRODUCTS IN OUR MANUFACTURING UNITS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571086 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1 Other