BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 8001761 · Received October 24, 2018

    Report

    Report Number
    1213809-2018-00746
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 12, 2018
    Report Date
    January 9, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. IT WAS REPORTED THAT 95 DEVICES WERE AFFECTED, BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. INVESTIGATION SUMMARY: THREE PHOTOS AND 98 PHYSICAL SYRINGE SAMPLES IN 6 PLASTIC ZIP LOCK BAGS WERE RECEIVED AND EVALUATED. THE SAMPLES WERE FROM AN UNKNOWN BATCH ¿ EITHER 6082996 OR 6089725, P/N 301029 ¿ AS REPORTED AND MARKED ON THE SAMPLE BAGS. 92 OF THE SAMPLES HAD OBVIOUS SIGNS OF USE AND CONTAMINATION. SOME OF THE SAMPLES HAD LABELS AND MOST HAD BLUE TIP CAPS ATTACHED. THE PLUNGER ON THE VAST MAJORITY OF THE SAMPLES WAS AT THE RETAINING RING PAST THE 10ML MARK. FLUID RESIDUE WAS OBSERVED THROUGHOUT THE FLUID PATH OF THE SYRINGES. MANY SYRINGES WERE FOUND TO HAVE FLUID RESIDUE BETWEEN THE STOPPER RIBS AS WELL AS BEHIND THE STOPPER AND ON THE PLUNGER RODS THEMSELVES. 6 OF THE SAMPLES IN A SEPARATE BAG DID NOT APPEAR TO HAVE MEDICATION RESIDUE AND WERE EVALUATED FOR SILICONE PRESENCE. 3 OUT OF 6 HAD NORMAL SILICONE CONTENT PER PRODUCT SPECIFICATION. 3 OUT OF 6 HAD EXCESSIVE SILICONE CONTENT WITH OBVIOUS STRINGING AND POOLING OF SILICONE ON THE STOPPER. THE AMOUNT IS REJECTABLE PER PRODUCT SPECIFICATION. NO TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE SAMPLES RECEIVED. ALL SAMPLES WERE CONTAMINATED AND NO REPRESENTATIVE SAMPLES FROM THE REPORTED LOTS WERE RECEIVED. THE BARRELS FROM THE REPORTED BATCHES IN THIS COMPLAINT HAD SLIGHT TAPER IN THEIR WALLS PER SPECIFICATION. IT IS A KNOWN CONDITION THAT MAY HAVE POTENTIALLY CONTRIBUTED TO THE LEAKAGE PAST STOPPER CONDITION. THE TOOLS HAVE SINCE BEEN UPGRADED ¿ CURRENT PRODUCTION MANUFACTURES BARRELS WITH NO TAPER WALLS. THEREFORE NO ADDITIONAL CORRECTIVE ACTIONS ARE NECESSARY. THE POTENTIAL ROOT CAUSE FOR EXCESS SILICONE IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED (TWO) LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. IT WAS REPORTED THAT 95 DEVICES WERE AFFECTED, BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    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 #: 6082996, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2016-03-22. MEDICAL DEVICE LOT #: 6089725, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2016-03-29. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WITH THE USE OF THE BD BD SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843505 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other