BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LEUR LOK SYRINGE

    MDR report key: 8473944 · Received April 2, 2019

    Report

    Report Number
    3003152976-2019-00234
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 12, 2019
    Report Date
    May 6, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO SAMPLES AND MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A PARTICLE WAS OBSERVED INSIDE THE SYRINGE ON THE STOPPER IN BOTH SAMPLES RECEIVED. USING MAGNIFICATION, THE PARTICLES WERE IDENTIFIED TO CONSIST OF FIBER AND PLASTIC. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1811354, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A BLOWING SYSTEM USED TO CLEAR PARTICLES IN THE BARREL PRIOR TO THE ASSEMBLY OF THE PLUNGER. PRODUCT UNDERGOES BOTH VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT THE MANUFACTURING TO AVOID ANY DEFECTS. WHILE WE CANNOT DETERMINE THE ORIGIN OF THE PARTICLES AND NO DIRECT ISSUE WERE IDENTIFIED, IT IS LIKELY THE PARTICLES FELL INTO THE SYRINGE IN THE ASSEMBLY STATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ LEUR LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 50ML SYRINGES SUPPLIED IN TRIPLE-WRAPPED IRRADIATED PACKS OF 10 BY HELAPET. EXCESS LUBRICANT/SILICONE, ESCAPING FROM PLUNGER INTO SYRINGE BARREL, MIXING WITH SYRINGE CONTENTS AND FORMING HARD CLEAR PARTICLES WHICH ARE THEN TRANSFERRED INTO INJECTABLE PATIENT MEDICINES. DETAILS OF INJURY: INVESTIGATION ONGOING TO DETERMINE "PATIENT" IMPACT. ACTION TAKEN: ALL MEDICATIONS MADE USING THIS PRODUCT HAVE BEEN RECALLED/REPLACED. INVESTIGATION ONGOING TO DETERMINE NUMBER OF PATIENTS AFFECTED/POTENTIAL IMPLICATIONS OF INJECTING SILICONE INTRAVENOUSLY INTO VULNERABLE PATIENTS. PLEASE PROVIDE CATALOG AND BATCH NUMBER OF THE AFFECTED PRODUCT ¿ WE BUY THESE PACKED DOWN BY HELAPET INTO PACKS OF 10, THEY HAVE TOLD US THE BD BATCH NUMBER IS 1811354. WHAT KIND OF A SUBSTANCE/MEDICATION WAS DRAW IN TO THE SYRINGE? ¿ WAS SPOTTED WITHOUT DRAWING ANYTHING UP, ALSO SPOTTED IN A COUPLE OF PRODUCTS THAT HAVE BEEN REJECTED SINCE. DID THE COURSE OF TREATMENT CHANGED ? - NO. WAS MEDICAL INTERVENTION NEEDED? - NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ LEUR LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 50ML SYRINGES SUPPLIED IN TRIPLE-WRAPPED IRRADIATED PACKS OF 10 BY (B)(4). EXCESS LUBRICANT/SILICONE, ESCAPING FROM PLUNGER INTO SYRINGE BARREL, MIXING WITH SYRINGE CONTENTS AND FORMING HARD CLEAR PARTICLES WHICH ARE THEN TRANSFERRED INTO INJECTABLE PATIENT MEDICINES. DETAILS OF INJURY: INVESTIGATION ONGOING TO DETERMINE PATIENT IMPACT. ACTION TAKEN: ALL MEDICATIONS MADE USING THIS PRODUCT HAVE BEEN RECALLED/REPLACED. INVESTIGATION ONGOING TO DETERMINE NUMBER OF PATIENTS AFFECTED/POTENTIAL IMPLICATIONS OF INJECTING SILICONE INTRAVENOUSLY INTO VULNERABLE PATIENTS. PLEASE PROVIDE CATALOG AND BATCH NUMBER OF THE AFFECTED PRODUCT ¿ WE BUY THESE PACKED DOWN BY (B)(4) INTO PACKS OF 10, THEY HAVE TOLD US THE BD BATCH NUMBER IS 1811354. WHAT KIND OF A SUBSTANCE/MEDICATION WAS DRAW IN TO THE SYRINGE? WAS SPOTTED WITHOUT DRAWING ANYTHING UP, ALSO SPOTTED IN A COUPLE OF PRODUCTS THAT HAVE BEEN REJECTED SINCE. DID THE COURSE OF TREATMENT CHANGED ? NO. WAS MEDICAL INTERVENTION NEEDED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269465 BD PLASTIPAK LEUR LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811354

    Patients

    Seq Age Sex Outcome Treatment
    1 Other