BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 8574421 · Received May 2, 2019

    Report

    Report Number
    3003152976-2019-00297
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 17, 2019
    Report Date
    June 27, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS AND ONE SAMPLE WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UNFORTUNATELY, WE ARE UNABLE TO LOCATE THE PHYSICAL SAMPLE AT THIS TIME. THROUGH VISUAL INSPECTION OF THE PHOTOS, A PARTICLE CAN BE OBSERVED INSIDE THE SYRINGE BARREL ON THE STOPPER. BASED ON THE PHOTO WE ARE NOT ABLE TO IDENTIFY HE ORIGIN OF THE PARTICLE. TEN RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR EVALUATION, NO FOREIGN MATTER WAS IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1810267, FINDING ONE ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING THE ASSEMBLY PROCESS, POLYPROPYLENE PARTICLES WERE DETECTED INSIDE THE SYRINGES. ONCE IDENTIFIED, THE MANUFACTURING PROCESS WAS STOPPED AND CLEANING WAS PERFORMED ACCORDING TO PROCEDURE. THESE PARTICLES GENERATE DURING THE TRANSPORT OF PIECES IN THE MANUFACTURING AREA. IT WAS DETERMINED THE REPORTED FAILURE IS RELATED TO THIS 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. A PROJECT WAS RECENTLY INITIATED TO EVALUATE AND FURTHER REDUCE FOREIGN MATTER WITHIN OUR PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN PARTICLES WERE OBSERVED IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE, USED TO PREPARE CYTOSTATIC SOLUTIONS, AND IN THE BLISTER PACKAGING BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE 1 OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CUSTOMER HAS BEEN USING BD PLASTIPAK SYRINGES FOR MORE THAN 20 YEARS TO PREPARE CYTOSTATIC SOLUTIONS VIA VOLUMETRIC DOSAGING. THEY USE NEEDLES OR SPIKES TO DRAW UP MEDICATION. DURING THE PAST 3 MONTHS, THEY HAVE BEEN FINDING PARTICLES INSIDE THE SYRINGE, BUT ALSO OUTSIDE THE SYRINGE INSIDE THE BLISTER. AMONG 300-400 PREPARATIONS, THEY FIND PARTICLES IN ABOUT 2-3 SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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 FOREIGN PARTICLES WERE OBSERVED IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE, USED TO PREPARE CYTOSTATIC SOLUTIONS, AND IN THE BLISTER PACKAGING BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE 1 OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CUSTOMER HAS BEEN USING BD PLASTIPAK SYRINGES FOR MORE THAN 20 YEARS TO PREPARE CYTOSTATIC SOLUTIONS VIA VOLUMETRIC DOSING. THEY USE NEEDLES OR SPIKES TO DRAW UP MEDICATION. DURING THE PAST 3 MONTHS, THEY HAVE BEEN FINDING PARTICLES INSIDE THE SYRINGE, BUT ALSO OUTSIDE THE SYRINGE INSIDE THE BLISTER. AMONG 300-400 PREPARATIONS, THEY FIND PARTICLES IN ABOUT 2-3 SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369533 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1810267

    Patients

    Seq Age Sex Outcome Treatment
    1 Other