BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9578329 · Received January 10, 2020

    Report

    Report Number
    1213809-2019-01341
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 19, 2019
    Report Date
    February 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO 10ML SYRINGES WERE RECEIVED AND EVALUATED. ONE WAS IN A FULLY SEALED BLISTER PACK FROM BATCH 9170956 (P/N302995) AND ONE WAS LOOSE. IT WAS OBSERVED THE LOOSE SYRINGE HAD A LENGTHWISE CRACK EXTENDING FORM THE 1.5ML TO THE 7.5ML MARKING OUTSIDE THE GRAD LINES, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. NO DEFECTS WERE OBSERVED ON THE SYRINGE FROM THE BLISTER PACK. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9170956 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACKED BARREL OCCURRED DURING USE WITH A BD SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THERE ARE CRACKS IN THE BARREL OF THE SYRINGES. I AM REPORTING AN ISSUE WITH BD 10 ML LUER-LOK SYRINGES REF 302995 LOT 917956. WE HAVE ENCOUNTERED 5 DIFFERENT SYRINGES WITH CRACKS IN THE BARREL. EMAIL RCVD 1/2/2010 - WE HAVE FOUND 5 - BD 10 ML SYRINGES LUER-LOK TODAY THAT HAD CRACKS IN THE BARREL. LOT 9170956. I HAVE REPORTED THE FINDING TO THE CUSTOMER SERVICE AT BD AND AM AWAITING A REPLY. HAS ANYONE ELSE HAD REPORTS?" 5 OCCURRENCES WERE REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACKED BARREL OCCURRED DURING USE WITH A BD SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THERE ARE CRACKS IN THE BARREL OF THE SYRINGES. I AM REPORTING AN ISSUE WITH BD 10 ML LUER-LOK SYRINGES REF 302995 LOT 917956. WE HAVE ENCOUNTERED 5 DIFFERENT SYRINGES WITH CRACKS IN THE BARREL. EMAIL RCVD 1/2/2010 - WE HAVE FOUND 5 - BD 10 ML SYRINGES LUER-LOK TODAY THAT HAD CRACKS IN THE BARREL. LOT 9170956. I HAVE REPORTED THE FINDING TO THE CUSTOMER SERVICE AT BD AND AM AWAITING A REPLY. HAS ANYONE ELSE HAD REPORTS?" 5 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41811 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 9170956 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other