BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 9395317 · Received December 2, 2019

    Report

    Report Number
    1213809-2019-01192
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 14, 2019
    Report Date
    December 12, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED AND EVALUATED. A PORTION OF A 1ML LL SYRINGE FROM APPROXIMATELY 0.2ML TO THE TIP, INCLUDING LUER COLLAR, WAS DEPICTED IN THE PHOTO. AN UNIDENTIFIED SHIELDED NEEDLE WAS ATTACHED TO THE SYRINGE. THE STOPPER WAS NOT VISIBLE IN THE PHOTO ¿ NOT IN THE ORIGINAL BOTTOM OUT POSITION, INDICATING POTENTIAL MANIPULATION OF THE PRODUCT. THE REPORTED ¿SMUDGE¿ WAS OBSERVED ON THE BARREL WALL NEAR THE ROOF AT THE ZERO LINE. IT WAS NOT POSSIBLE TO DEFINITIVELY IDENTIFY WHAT CAUSED IT FROM THE PHOTO PROVIDED AND WITHOUT A PHYSICAL SAMPLE. IT IS POSSIBLE IT WAS RESIDUE OF SILICONE USED DURING ASSEMBLY OF THE SYRINGE. IT IS POSSIBLE IT WAS RESIDUE OF ANOTHER SUBSTANCE AS A RESULT OF THE SAMPLE¿S MANIPULATION. SINCE THE SAMPLE HAD BEEN MANIPULATED, IT WAS NOT POSSIBLE TO DETERMINE WHAT THE ¿SMUDGE¿ IN THE PHOTO WAS. IT IS POSSIBLE IT WAS RESIDUE OF SILICONE USED DURING ASSEMBLY OF THE SYRINGE. IT IS ALSO POSSIBLE IT WAS RESIDUE OF ANOTHER SUBSTANCE AS A RESULT OF THE SAMPLE¿S MANIPULATION. PHYSICAL SAMPLE IS REQUIRED TO BETTER DETERMINE THE NATURE OF THE FM. 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. 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 1ML SYRINGE LUER-LOK¿ TIP HAD FOREIGN MATTER ON IT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628, BATCH NO: 9003925. IT WAS REPORTED THAT A FILM/SMUDGE WAS NOTICED INSIDE THE SYRINGE BEFORE USE. ON (B)(6) 2019, THE REPORTER CONTACTED MEDICAL INFORMATION VIA PHONE TO REQUEST REPLACEMENT OF 1 VIAL OF EYLEA BECAUSE THE DOCTOR LEFT A NOTE STATING THE SYRINGE WAS DEFECTIVE. UPON CLARIFICATION, THE REPORTER STATED THERE WAS A FILM INSIDE THE SYRINGE. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. SHE STATED ALL SHE SAW WAS A SMUDGE IN THE SYRINGE BUT SHE WAS NOT SURE IF THAT WAS THE FILM THAT THE PHYSICIAN SAW.

    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 1ML SYRINGE LUER-LOK¿ TIP HAD FOREIGN MATTER ON IT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628 BATCH NO: 9003925. IT WAS REPORTED THAT A FILM/SMUDGE WAS NOTICED INSIDE THE SYRINGE BEFORE USE. ON (B)(6) 2019, THE REPORTER CONTACTED MEDICAL INFORMATION VIA PHONE TO REQUEST REPLACEMENT OF 1 VIAL OF EYLEA BECAUSE THE DOCTOR LEFT A NOTE STATING THE SYRINGE WAS DEFECTIVE. UPON CLARIFICATION, THE REPORTER STATED THERE WAS A FILM INSIDE THE SYRINGE. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. SHE STATED ALL SHE SAW WAS A SMUDGE IN THE SYRINGE BUT SHE WAS NOT SURE IF THAT WAS THE FILM THAT THE PHYSICIAN SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193796 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9003925 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other