BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN122 W/O PUMP T-TYPE

    MDR report key: 11507153 · Received March 17, 2021

    Report

    Report Number
    2243072-2021-00815
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/22/2021. H.6. INVESTIGATION: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. TAPER GAGE INSPECTION OF THE COMPLAINT SAMPLE: SBDM INSPECTED THE RECEIVED COMPLAINT SAMPLE AND RETENTION SAMPLES OF THE COMPONENTS (LOT NO. 201208 & 210219), TAPER GAGE OF ADAPTER IN THE SAMPLES ARE IN SPEC. INVESTIGATION UNDER NORMAL CONDITION OF USING CONDITION FOR THE AN122: SBDM CONNECT THE TIP OF COMPLAINT SAMPLE AND RECEIVED SAMPLE FILTER BUT, THERE WAS NO LEAKAGE IN THE AN122 SAMPLE. INVESTIGATION UNDER HIGH PRESSURE OF USING CONDITION FOR THE AN122: SBDM FILL MEDICINE INTO THE SPIKE & CHAMBER UNDER HIGH PRESSURE (0.72MPA), THERE WAS NO LEAKAGE IN THE AN122 TIP. TAPER GAGE INSPECTION OF THE HOUSE SAMPLES: SBDM INSPECTED THE LOT NO. (LOT NO. 2101131, 2101213 & 2101262) AS OF THE HOUSE SAMPLES, TAPER GAGE OF ALL ADAPTER OF HOUSE SAMPLES ARE IN SPEC. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 2101131, 2101213 & 2101262), THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE (LOT NO. 2101131, 2101213 & 2101262), THERE IS NO SAME ISSUE OF THE SAME PRODUCT (IV SET AN122 W/O PUMP T-TYPE) FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATIONS, SBDM HAD INSPECTED THE COMPLAINT SAMPLE & HOUSE SAMPLES, THERE WAS NO ISSUE ON ADAPTER TIP OF COMPLAINT SAMPLE. SBDM ALSO INSPECTED ADAPTOR TIP COMPONENTS (1SHOT = 60EA) BUT, ALL COMPONENTS WERE IN SPEC. SBDM REVIEW INJECTION MOLDING PROCESS OF ADAPTER, THERE WAS NO ISSUE TOO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV SET AN122 W/O PUMP T-TYPE WAS DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SET TIP WAS EASILY DISCONNECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 IV SET AN122 W/O PUMP T-TYPE WAS DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SET TIP WAS EASILY DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406588 IV SET AN122 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1