BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE

    MDR report key: 9310127 · Received November 12, 2019

    Report

    Report Number
    1213809-2019-01129
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 21, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND THREE LOOSE 5ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN THE PHOTO AND THE PHYSICAL SAMPLES THE PLUNGER RODS EACH HAD A SINGLE BROKEN RIB AND WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS LIKELY THE REPORTED DIAL JAMS CAUSED THE BROKEN PLUNGER RODS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9210551 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, 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 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE PLUNGER WAS DAMAGED. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301027, BATCH NO. 9210551. IT WAS REPORTED SYRINGES WERE FOUND WITH DAMAGE TO THE PLUNGER. DESCRIPTION OF NONCONFORMANCE: WHILE PERFORMING THE INCOMING INSPECTION ON THIS BATCH, THE INSPECTOR FOUND THAT 3 OUT OF 125 HAD DAMAGE TO THE PLUNGER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE PLUNGER WAS DAMAGED. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301027 BATCH NO. 9210551. IT WAS REPORTED SYRINGES WERE FOUND WITH DAMAGE TO THE PLUNGER. DESCRIPTION OF NONCONFORMANCE: WHILE PERFORMING THE INCOMING INSPECTION ON THIS BATCH, THE INSPECTOR FOUND THAT 3 OUT OF 125 HAD DAMAGE TO THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103196 BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9210551

    Patients

    Seq Age Sex Outcome Treatment
    1 Other