BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 10057580 · Received May 14, 2020

    Report

    Report Number
    1213809-2020-00308
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 23, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-01. INVESTIGATION SUMMARY: A TOTAL OF ELEVEN LOOSE 10ML SYRINGES IN VARIOUS CONDITION WERE RECEIVED IN MULTIPLE BAGS AND LOOSE IN THE BOX WITHOUT ANY BATCH IDENTIFICATION. NUMBER (B)(4) WAS WRITTEN ON THE PAPER BAGS. THE SAMPLES WERE VISUALLY EVALUATED. THE CRACKS WERE NOT STRAIGHT. SYRINGES WERE LOOSE IN THE BOX. THEY DID NOT APPEAR TO HAVE BEEN USED. ALL SYRINGES HAD LENGTHWISE CRACKS IN THEIR BARREL WALLS. ONE SYRINGE HAD A SHORT CRACK WITH SCUFF MARKS INDICATING A POTENTIAL IMPACT AREA AROUND 6ML MARKING. ONE SYRINGE HAD TWO LONG UNEVEN CRACKS. IT HAD SCUFF MARKS AND A POTENTIAL IMPACT POINT AT THE LEVEL OF THE LOGO MARKING. ONE SYRINGE HAD A LONG AND A SHORT CRACK. IT HAD SCUFF MARKS AND A POTENTIAL IMPACT POINT AT THE 7ML MARKING OF ONE CRACK. 3 SYRINGES WERE IN A SEALED PAPER-PLASTIC PACKAGE. THEY HAD CUSTOMER TIP CAPS ATTACHED AND UNIDENTIFIED LIQUID RESIDUE IN THE FLUID PATH. THE PLUNGERS WERE DRAWN TO 5-7ML MARKINGS. THE BARRELS OF ALL 3 SYRINGES HAD LENGTHWISE CRACKS IN THEM, WITH ONE HAVING TWO CRACKS. ONE SYRINGE HAD AN IMPACT POINT AT APPROXIMATELY 9ML MARKING. ONE SYRINGE HAD AN IMPACT POINT AT THE LEVEL OF 10ML MARKING. ONE SYRINGE HAD AN APPARENT IMPACT POINT AT JUST ABOVE BD LOGO LEVEL. 1 SYRINGE WAS IN AN OPENED PAPER-PLASTIC PACKAGE. IT HAD A SINGLE UNEVEN LENGTHWISE CRACK IN THE BARREL. THERE WAS A CLEAR IMPACT POINT IN THE CRACK AT JUST ABOVE THE BD LOGO LEVEL. 4 SYRINGES WERE IN A SEALED PAPER-PLASTIC PACKAGE. IT WAS NOT CLEAR WHETHER THESE SYRINGE HAD BEEN USED AS THERE APPEARED TO BE SMALL AMOUNTS OF UNIDENTIFIED DRIED RESIDUE AROUND THE SAMPLES¿ COMPONENTS. ONE SYRINGE HAD A SINGLE CRACK WITH A SCUFF MARK AND POTENTIAL IMPACT AREA AROUND 6ML MARKING. ONE SYRINGE HAD TWO LARGE CRACK WITH ONE EXTENDING TO, AND SPLITTING, THE FLANGE. THERE APPEARED TO BE TWO IMPACT POINTS ¿ ONE ON EACH CRACK ¿ AT 9ML MARKING AND AT THE LEVEL OF 8ML MARKING. ONE SYRINGE HAD A SINGLE SHORT CRACK WITH SCUFF MARKS LEADING TO IT AND A POTENTIAL IMPACT POINT AT 6ML MARKING LEVEL. ONE SYRINGE HAD A SINGLE CRACK WITH NO CLEAR IMPACT POINT BUT MULTIPLE SMALL SCUFF MARKS AROUND THE BARREL. INVESTIGATION INTO THE BULK NON-STERILE PACKAGING PROCESS REVEALED THERE ARE SITUATIONS THAT MAY ARISE RESULTING IN A HOPPER JAM AND INABILITY OF THE PROCESS TO SELF-CORRECT THESE SITUATIONS. THESE SITUATIONS WOULD NECESSITATE OPERATOR INTERVENTIONS, WHICH CARRY INHERENT RISK OF DAMAGING PRODUCT WITH TOOLING WHILE CLEARING THE JAM. A POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL IS DUE TO LACK OF CONTROLS TO PREVENT JAM IN THE PACKAGING PROCESS. A PREVENTION PROCESS PLAN WILL BE ADJUSTED TO INCLUDE EARLY DETECTION OF PART BUILDUP TO PREVENT JAMS BY SHUTTING OFF PRODUCT FLOW TO THE AREA IDENTIFIED IN THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS THAT THE SYRINGES ARE CRACKED. THIS IS THE SECOND COMPLAINT WITH THIS PROBLEM.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8171755, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-06-20, MEDICAL DEVICE LOT #: 8193905, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: 2018-07-12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS THAT THE SYRINGES ARE CRACKED. THIS IS THE SECOND COMPLAINT WITH THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518451 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other