BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 16716211 · Received April 11, 2023

    Report

    Report Number
    1911916-2023-00229
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 22, 2023
    Report Date
    July 22, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    UDI-DI
    00382903065462
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECTON DICKINSON AND COMPANY (BD) WOULD LIKE TO USE THIS OPPORTUNITY TO PROVIDE INFORMATION REGARDING THE STORAGE REQUIREMENTS OF THE BD¿ POSIFLUSH SALINE SYRINGES. BD¿ POSIFLUSH SALINE SYRINGES ARE LABELED FOR TEMPERATURE CONTROL: ¿STORE AT 20 ¿ 25°C (68 ¿ 77°F); EXCURSIONS PERMITTED TO 15 ¿ 30°C (59 ¿ 86°F); DO NOT FREEZE. THESE CONDITIONS REPRESENT THE REQUIREMENTS FOR ¿CONTROLLED ROOM TEMPERATURE¿. BASED ON USP <659> PACKAGING AND STORAGE REQUIREMENTS, PRODUCT STORED AT CONTROLLED ROOM TEMPERATURE MAY ALTERNATIVELY BE STORED AND SHIPPED IN A ¿COOL PLACE¿ OR ¿REFRIGERATOR¿, UNLESS OTHERWISE SPECIFIED ON THE LABEL. FOR BD POSIFLUSH, TEMPORARY STORAGE OF PRODUCT BETWEEN THE TEMPERATURES OF 2 ¿ 15°C (36 ¿ 59°F) WOULD BE ACCEPTABLE, IF REQUIRED. THE BD¿ POSIFLUSH SALINE SYRINGES CAN ACCOMMODATE SHORT TERM TEMPERATURE EXCURSIONS WITHIN CERTAIN TIME LIMITS. IF A TEMPERATURE EXCURSION HAS OCCURRED, PLEASE FEEL FREE TO CONTACT YOUR BD SALES REP, A CUSTOMER SERVICE REP, OR ME FOR ASSISTANCE ASSESSING THE PRODUCT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D2: MEDICAL DEVICE TYPE: FOZ D4: MEDICAL DEVICE LOT #: 2354585 D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025 H4: DEVICE MANUFACTURE DATE: 20-DEC-2022 D4: MEDICAL DEVICE LOT #: 3011573 D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025 H4: DEVICE MANUFACTURE DATE: 01-JAN-2023 D4: MEDICAL DEVICE LOT #: 3012139 D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025 H4: DEVICE MANUFACTURE DATE: 12-JAN-2023 D4: MEDICAL DEVICE LOT #: 3017680 D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025 H4: DEVICE MANUFACTURE DATE: 17-JAN-2023 D4: MEDICAL DEVICE LOT #: 3004996 D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025 H4: DEVICE MANUFACTURE DATE: 04-JAN-2023 D4: MEDICAL DEVICE LOT #: 2354589 D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025 H4: DEVICE MANUFACTURE DATE: 20-DEC-2022

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS RECEIVED FROZEN AT 35F. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "******* RECEIVED THIS INBOUND TODAY... THE TEMP WAS SET TO 34F, ACTUAL READING OF 35F. THE SPECIAL INSTRUCTIONS SAY "DO NOT FREEZE. KEEP TEMP BETWEEN 39F AND 86F.""

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS RECEIVED FROZEN AT 35F. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " RECEIVED THIS INBOUND TODAY. THE TEMP WAS SET TO 34F, ACTUAL READING OF 35F. THE SPECIAL INSTRUCTIONS SAY "DO NOT FREEZE. KEEP TEMP BETWEEN 39F AND 86F.""

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773789 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 2354589 00382903065462
    667285 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 2354589 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown