BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LS 200 S/C

    MDR report key: 8487622 · Received April 5, 2019

    Report

    Report Number
    1213809-2019-00415
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 19, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: DATE OF EVENT: (B)(6) 2019 WAS CHANGED TO (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO SHELF CARTONS TAPED TOGETHER WERE RECEIVED, CONFIRMED TO BE FROM BATCH #8213921 (P/N 309659). THE SYRINGES INSIDE WERE VISUALLY EVALUATED. 57 OUT OF 400 SYRINGES WERE FOUND TO HAVE CLOUDY TIPS. CLOUDY TIPS ARE A RESULT OF NORMAL MOLDING PROCESS. OVER TIME A SMALL AMOUNT OF PLASTIC BUILD UP OR RESIDUE OCCURS IN THE MOLD CAUSING THIS DEFECT. IT IS REMEDIED BY POLISHING THE MOLD. THE CLOUDY TIP DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. 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. THE DEFECT OBSERVED IS CONSIDERED COSMETIC AND ACCEPTABLE PER PRODUCT SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SHELF OF PACK BD¿ SYRINGE LS 200 S/C WERE CLOUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ THE SYRINGES WERE CLOUDY AND THEREFORE UNUSABLE. THE SALES REP WAS NOTIFIED LAST THURSDAY (3/21) OF THIS EVENT; HOWEVER, REPORTER STATES THE PRODUCT WAS SENT TO THE CUSTOMER IN JAN. CUSTOMER HAS TWO SHELF PACKS OF PRODUCT. ¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SHELF OF PACK BD¿ SYRINGE LS 200 S/C WERE CLOUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ THE SYRINGES WERE CLOUDY AND THEREFORE UNUSABLE. THE SALES REP WAS NOTIFIED LAST THURSDAY (3/21) OF THIS EVENT; HOWEVER, REPORTER STATES THE PRODUCT WAS SENT TO THE CUSTOMER IN JAN. CUSTOMER HAS TWO SHELF PACKS OF PRODUCT. ¿

    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 TWO SHELF OF PACK BD¿ SYRINGE LS 200 S/C WERE CLOUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE SYRINGES WERE CLOUDY AND THEREFORE UNUSABLE. THE SALES REP WAS NOTIFIED LAST THURSDAY (3/21) OF THIS EVENT; HOWEVER, REPORTER STATES THE PRODUCT WAS SENT TO THE CUSTOMER IN JAN CUSTOMER HAS TWO SHELF PACKS OF PRODUCT. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282555 BD SYRINGE LS 200 S/C SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8213921 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other