BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 11362920 · Received February 22, 2021

    Report

    Report Number
    1213809-2021-00094
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 26, 2021
    Report Date
    March 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/5/2021. H.6. INVESTIGATION: FOUR PHOTOS EACH DISPLAYING A LOOSE 10ML SYRINGE AND SEVEN LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. TWO PHOTOS DISPLAYED SYRINGES WITH MISSING PRINT. ONE SYRINGE HAD MULTIPLE AREAS OF MISSING PRINT BETWEEN THE 2ML AND 3ML MARKINGS, THE 4ML AND 6ML MARKINGS AND THE 8ML AND 10ML MARKINGS. AT LEAST ONE PRINTED ITEM WAS MISSING MORE THAN 50%, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE HAD A SMALL AREA OF MISSING PRINT BETWEEN THE 6ML AND 7ML MARKINGS BUT WAS ACCEPTABLE PER PRODUCT SPECIFICATION. FIVE LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. THE FIVE SYRINGES HAD SIMILAR MISSING TO PRINT WHAT WAS SHOWN IN THE PHOTOS. THE PRINT APPEARED TO BE SCRATCHED OFF AS SCUFF MARKS WERE PRESENT IN THE CONSISTENT LOCATIONS. ALL FIVE OF THE PHYSICAL SAMPLES RECEIVED HAD LESS THAN 50% OF ANY ONE ITEM MISSING, WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. TWO PHOTOS DISPLAYING A SYRINGE WITH THE STOPPER NOT ATTACHED TO THE PLUNGER ROD AND FACING THE WRONG DIRECTION. THERE WAS ALSO PLUNGER ROD DAMAGE PRESENT IN EACH PHOTO WITH ONE DISPLAYING A BROKEN RIB WITH A PORTION OF THE RIB MISSING AND ONE RIB HAVING A WAVE-LIKE DEFORMATION. THE SYRINGE WAS REJECTABLE PER PRODUCT SPECIFICATION. TWO LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE ONE SYRINGES APPEARED TO BE THE ONE DISPLAYED IN BOTH PHOTOS. BOTH SYRINGES HAD SIMILAR PLUNGER ROD DAMAGE WITH ONE BROKEN RIB AND ONE WAVE-LIKE DEFORMED RIB AND WELL AS A SMALL PORTION OF THE THUMB REST BROKEN OFF. ONE SYRINGE ALSO HAD THE STOPPER DETACHED FROM THE PLUNGER ROD AND FACING THE WRONG DIRECTION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT WAS LIKELY DUE TO A BARREL JAM CAUSING THE PRINT TO BECOME RUBBED OFF. POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD AND MISORIENTED STOPPER DEFECTS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS LIKELY THERE WAS A PLUNGER ROD FEEDING ISSUE THAT REQUIRED INTERVENTION, WHICH MAY HAVE INADVERTENTLY CAUSED THE MISORIENTED STOPPER DURING ASSEMBLY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 SYRINGE 10ML LL BNS HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED SCALE MARKINGS DAMAGED. VERBATIM: THERE ARE AROUND 10 DEFECTIVE PARTS THAT HAVE BEEN FOUND OUT OF APPROXIMATELY 10K INSPECTED SO FAR. THE TOTAL LOT SIZE RECEIVED FROM VWR WAS (B)(4) PARTS. 24 CS IS WHAT THE CUSTOMER ORDERED AND THOSE WERE THE ONLY ISSUES WITH THIS ITEM WITH LOT#0211688. THEY ALSO ADVISED THAT LOT#0059942 HAD 5 SYRINGES WITH THE CONDITION SHOWN BELOW. DO YOU WANT THOSE SAMPLES AS WELL? FOR BOTH OF THESE LOT NUMBERS NOBODY WAS HURT. PLEASE LET ME NOW IF YOU NEED ANY OTHER INFO. YOUR ASSISTANCE IS GREATLY APPRECIATED. HAVE A GOOD DAY!"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 25 SYRINGE 10ML LL BNS HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED SCALE MARKINGS DAMAGED. VERBATIM: THERE ARE AROUND 10 DEFECTIVE PARTS THAT HAVE BEEN FOUND OUT OF APPROXIMATELY 10K INSPECTED SO FAR. THE TOTAL LOT SIZE RECEIVED FROM VWR WAS 20,400 PARTS. 24 CS IS WHAT THE CUSTOMER ORDERED AND THOSE WERE THE ONLY ISSUES WITH THIS ITEM WITH LOT#0211688. THEY ALSO ADVISED THAT LOT#0059942 HAD 5 SYRINGES WITH THE CONDITION SHOWN BELOW. DO YOU WANT THOSE SAMPLES AS WELL? FOR BOTH OF THESE LOT NUMBERS NOBODY WAS HURT. PLEASE LET ME NOW IF YOU NEED ANY OTHER INFO. YOUR ASSISTANCE IS GREATLY APPRECIATED. HAVE A GOOD DAY!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256023 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0059942

    Patients

    Seq Age Sex Outcome Treatment
    1