BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

    MDR report key: 12380266 · Received August 27, 2021

    Report

    Report Number
    1213809-2021-00602
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 6, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED AND EVALUATED. A LOOSE 3ML SYRINGE WITH ABOUT 0.5ML OF CLEAR LIQUID AND THE STOPPER AT 1ML LINE WAS SHOWN IN THE PHOTO. AN UNIDENTIFIED SUBSTANCE IN A SHAPE OF A BAND WAS OBSERVED ON THE INSIDE OF THE BARREL BETWEEN 0.2 AND 0.4ML GRAD LINES. THE SUBSTANCE APPEARED TO BE COLORLESS OPAQUE. THE SUBSTANCE COULD NOT BE IDENTIFIED BASED ON THE PHOTO PROVIDED. BASED ON THE VERBATIM, THE REPORTED DEFECT WAS NOT PRESENT DURING THE INITIAL UNPACKING AND USE OF THE PRODUCT. WITHOUT A SAMPLE TO IDENTIFY THE FOREIGN MATTER AND DUE TO THE PRODUCT HAVING BEEN MANIPULATED, THE DEFECT COULD NOT BE CONFIRMED TO HAVE ORIGINATED AT THE MANUFACTURING PLANT, THEREFORE CORRECTIVE ACTIONS ARE NOT NECESSARY. PHYSICAL SAMPLE IS REQUIRED TO HELP IDENTIFY THE FOREIGN MATTER AND FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD REVIEW SHOWED QUALITY NOTIFICATION WAS ISSUED FOR LOT# 0161846 FOR POTENTIAL BARREL CONTAMINATION FROM MOLDING PROCESS. PRODUCT WAS INSPECTED AND REQUALIFIED PER APPLICABLE ACCEPTABLE QUALITY LIMIT. BATCH# 0161846 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO REJECTED INSPECTIONS OR QUALITY ISSUES OBSERVED DURING THE PRODUCTION OF THE BATCH# 0178006 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A UNIT DOSE WAS DISPENSED, VISUALLY INSPECTED AFTER MANIPULATION AND DISTRIBUTED TO THE CUSTOMER. AT THE CUSTOMER'S SITE, THERE WAS "CRYSTALLIZATION" INSIDE THE BARREL OF THE SYRINGE AS THE CUSTOMER CLAIMED. THE PATIENT DID NOT RECEIVE THE DOSE, IT WAS NOT USED. THE CUSTOMER MENTIONED THAT, ¿SEEMS TO HAVE SORT OF CRYSTALIZED LAYER ON THE INSIDE OF THE SYRINGE. PERHAPS A BAD SYRINGE?¿

    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 THE BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A UNIT DOSE WAS DISPENSED, VISUALLY INSPECTED AFTER MANIPULATION AND DISTRIBUTED TO THE CUSTOMER. AT THE CUSTOMER'S SITE, THERE WAS "CRYSTALLIZATION" INSIDE THE BARREL OF THE SYRINGE AS THE CUSTOMER CLAIMED. THE PATIENT DID NOT RECEIVE THE DOSE, IT WAS NOT USED. THE CUSTOMER MENTIONED THAT, ¿SEEMS TO HAVE SORT OF CRYSTALIZED LAYER ON THE INSIDE OF THE SYRINGE. PERHAPS A BAD SYRINGE?¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276170 BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309575 UNKNOWN 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1