BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 20913313 · Received December 12, 2024

    Report

    Report Number
    1213809-2024-00946
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 18, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE WERE MULTIPLE DEFECTS FOUND WITH THE BATCH RECEIVED. TO AID IN THE INVESTIGATION, FORTY SAMPLES OF 5ML LUER LOK SYRINGES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ALL THE SAMPLES WERE RECEIVED LOOSE IN MULTIPLE SMALL BAGS SEPARATED BY OBSERVED DEFECTS. TWENTY-TWO SAMPLES WERE RECEIVED FOR A DISTORTED STOPPER CONDITION; THREE SYRINGES HAD NO DEFECTS, AND NINETEEN SAMPLES HAVE THE STOPPER JAMMED BETWEEN THE BARREL AND PLUNGER. SIX SAMPLES HAD SILICONE OBSERVED ON THE STOPPER; HOWEVER, FIVE SAMPLES HAD NO POOLING OR STRINGING, WHICH IS ACCEPTABLE. ONE SYRINGE WAS FOUND TO HAVE SLIGHT STRINGING OF THE SILICONE; THIS IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. FIVE SAMPLES WERE LABELED AS EMBEDDED OR INK DOTS. NO EMBEDDED FOREIGN MATTER WAS OBSERVED, BUT FOUR SAMPLES WERE FOUND TO HAVE INK DOTS ON THE BARREL. TWO WERE ACCEPTABLE AND TWO WERE DEFECTIVE. ONE HAD DAMAGE TO THE BARREL FLANGE WITH A BLACK MARK IN THE AREA FROM THE DAMAGE. FOUR SAMPLES WERE LABELED AS DAMAGED; ONE SYRINGE HAD A SLIGHT SCRATCH THAT DOES NOT AFFECT FORM, FIT OR FUNCTION, ONE WITH A LARGE SCUFF, ONE WITH FLANGE DAMAGE, AND ONE WITH MAJOR TIP DAMAGE. OF THE LAST THREE SYRINGES RETURNED, ONE HAD A SLIGHT ACCEPTABLE SCRATCH, ONE HAD THE FLANGE DAMAGED, AND ONE HAD EXCESSIVE INK DOTS ON THE SYRINGE BARREL. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. THE INK DOTS ARE ASSOCIATED WITH THE MARKING PROCESS. THE EXCESSIVE SILICONE, BARREL FLANGE DAMAGE, SCRAPES, JAMMED STOPPERS AND BARREL TIP DAMAGE ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. 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. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301027, LOT 2152955. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED PER REQUIREMENTS WITH NO QUALITY NOTIFICATIONS RELATED TO THE DEFECT REPORTED. THE LOT WAS INSPECTED AND ACCEPTED BASED ON OUR INSPECTION CONTROL PLAN AND APPROVED FOR SHIPMENT. THESE CONDITIONS ARE OCCURRING AT BELOW THEIR EXPECTED FREQUENCY. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS AGREED, WE SUBMIT ALL OUR FINDINGS AT THE END OF THE BATCH. ALL WERE FOUND DURING PACKAGING SO NO PATIENTS WERE INVOLVED. NONE OF THE DEVIATIONS ARE CONSIDERED HIGH-RISK. ARTICLE CODE: 301027 BATCH: 2152955 EVENT DATE: 06-OCT-2023 TILL 15 NOV 2024 STAXS COMPLAINT REFS: 9725, (B)(4. VISIBLE SILICON OIL: 141 SCALE MARKING ISSUE: 2 STOPPER ISSUE: 44 DAMAGED TIP: 1 DAMAGED SYRINGE: 3 BURNED FLANGE: 1 EMBEDDED MATTER/INK: 4 SAMPLES ARE AVAILABLE AND CAN BE PICKED UP AT THE FOLLOWING LOCATION: (B)(6). THE NETHERLANDS COLLECTION POINT: EXPEDITION PHONE NUMBER: +(B)(6) EMAIL ADDRESS: (B)(6)..

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155247 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2152955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown