BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD OPTIMA CONNECTOR

    MDR report key: 11750633 · Received April 29, 2021

    Report

    Report Number
    2243072-2021-01299
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 30, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED. WHILE THE SPECIFIC LOTS WERE NOT PROVIDED, TWO EXPIRATION DATES OF 2021-02-28 AND 2021-01-31 WERE REFERENCED. BASED ON THIS INFORMATION, WE WERE ABLE TO IDENTIFY THE FOLLOWING LOTS WITH THE REPORTED EXPIRATION DATES; 2002101, 2002102, 2002103, 2003103. WHEN REVIEWING DISTRIBUTION RECORDS OF THE SUSPECTED LOTS, IT WAS VERIFIED ALL LOTS WERE NOT EXPIRED WHEN SENT TO THE FACILITY. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO VERIFY THE REPORTED ISSUE OR IDENTIFY ANY DEFECT WITH OUR PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ OPTIMA CONNECTOR WAS EXPIRED. THIS OCCURRED ON 98 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN   IT WAS REPORTED THAT PHASEAL OPTIMA CONNECTORS FOUND TO BE EXPIRED: 48 ITEMS EXPIRED ON 2021-02-28 AND 50 ITEMS EXPIRED ON 2021-01-31.   VERBATIM: BD 092- REPORTED DATE: 03/30/21 . EVENT DATE: 03/30/21 ITEM NUMBER: NOT REPORTED; LOT NUMBER: NOT REPORTED; ITEM RETAINED IN DEFECT DEPOT?: NOT REPORTED; PICTURE: NOT REPORTED. WHILE A COWORKER WAS PERFORMING SAFETY 365 SHE HAD NOTICED AN EXPIRED PHASEAL OPTIMA CONNECTOR. SO I WENT THROUGH AND SEARCHED FOR ALL EXPIRED ITEMS. THESE ITEMS HAD TO BEEN STOCKED IN OUR PAR ROOM RECENTLY AS WE DID AN AUDIT JUST THE OTHER DAY. ALSO THE BIN HAD RECENTLY BEEN EMPTIED BECAUSE THE NURSES STOCK THEIR MED SUPPLY ROOM. I BELIEVE THAT THE PAR WAS STOCKED WITH THE EXPIRED SUPPLIES. ALL OF THE EXPIRED SUPPLIES WERE FOUND IN PAR ROOM WLC3.1412. PHASEAL OPTIMA CONNECTORS: 48 ITEMS EXPIRED ON 2021-02-28 AND 50 ITEMS EXPIRED ON 2021-01-31.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD" OPTIMA CONNECTOR WAS EXPIRED. THIS OCCURRED ON 98 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. ¿ IT WAS REPORTED THAT PHASEAL OPTIMA CONNECTORS FOUND TO BE EXPIRED: 48 ITEMS EXPIRED ON 2021-02-28 AND 50 ITEMS EXPIRED ON 2021-01-31. ¿ VERBATIM: BD 092- REPORTED DATE: (B)(6) 2021 EVENT DATE: (B)(6) 2021 ITEM NUMBER: NOT REPORTED. LOT NUMBER: NOT REPORTED. ITEM RETAINED IN DEFECT DEPOT?: NOT REPORTED, PICTURE: NOT REPORTED. WHILE A COWORKER WAS PERFORMING SAFETY 365 SHE HAD NOTICED AN EXPIRED PHASEAL OPTIMA CONNECTOR. SO I WENT THROUGH AND SEARCHED FOR ALL EXPIRED ITEMS. THESE ITEMS HAD TO BEEN STOCKED IN OUR PAR ROOM RECENTLY AS WE DID AN AUDIT JUST THE OTHER DAY. ALSO THE BIN HAD RECENTLY BEEN EMPTIED BECAUSE THE NURSES STOCK THEIR MED SUPPLY ROOM. I BELIEVE THAT THE PAR WAS STOCKED WITH THE EXPIRED SUPPLIES. ALL OF THE EXPIRED SUPPLIES WERE FOUND IN PAR ROOM (B)(4). PHASEAL OPTIMA CONNECTORS: 48 ITEMS EXPIRED ON 2021-02-28 AND 50 ITEMS EXPIRED ON 2021-01-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646660 UNSPECIFIED BD OPTIMA CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1