BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 9519869 · Received December 26, 2019

    Report

    Report Number
    1213809-2019-01302
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ONE PHOTO AND THIRTY-TWO LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN THE PHOTOS AND ALL THE PHYSICAL SAMPLES THERE WAS BARREL DAMAGE PRESENT WITH TWENTY-FOUR OF THE SYRINGES ALSO CONTAINING PLUNGER ROD DAMAGE. THE BARREL DAMAGE CONSISTED OF SCRATCHES AND DEFORMATIONS AS WELL AS BROKEN AND DEFORMED FLANGES. THE PLUNGER ROD DAMAGE CONSISTED OF A BROKEN OR CRACKED RIB. THE DAMAGE PRESENT ON ALL SAMPLES WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL AND PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE REJECTION MECHANISM AT THE ASSEMBLY DIALS WAS MALFUNCTIONING CAUSING JAMS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9190728 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DHR WAS PERFORMED RELEASE DATE: 7/17/2019. RELEASED QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH A QUALITY NOTIFICATION ISSUED FOR DAMAGE. BATCH 9190728 WAS REQUALIFIED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 10ML SYRINGE LUER-LOK¿ TIP PLUNGER WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE NOTICED SEVERAL DEFECTS ON THE SYRINGES: BROKEN, WITH A BREACH, MELTED WITH BROKEN PLUNGERS. WE FOUND 352 DEVICES NON COMPLIANT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 10ML SYRINGE LUER-LOK¿ TIP PLUNGER WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE NOTICED SEVERAL DEFECTS ON THE SYRINGES: BROKEN, WITH A BREACH, MELTED WITH BROKEN PLUNGERS. WE FOUND 352 DEVICES NON COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316968 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9190728

    Patients

    Seq Age Sex Outcome Treatment
    1 Other