BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 17395828 · Received July 26, 2023

    Report

    Report Number
    2523676-2023-00375
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 29, 2023
    Manufacturer
    B BRAUN MEDICAL INC
    Product Code
    FPA
    UDI-DI
    04046964298219
    PMA / PMN Number
    K942988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). SECTION A: EVALUATOR INFORMATION. EVALUATOR NAME: (B)(6). EVALUATOR TITLE: PIR TECHNICIAN. DATE(S) OF EVALUATION: AUGUST 10, 2023. SECTION B: CONDITION OF RETURNED SAMPLES. SAMPLE STATUS: [] NO SAMPLE RETURNED [X] SAMPLE RETURNED. PICTURES ATTACHED: [ ] YES [X] NO. CONDITION OF SAMPLES: ONE THOUSAND ONE HUNDRED TWO UNUSED SAMPLES WITH ORIGINAL PACKAGING RETURNED FOR EVALUATION. SECTION C: INSPECTION & TESTING OF RETURNED SAMPLES SPECIFICATION/TEST METHOD(S): SPEC-MD- 2000617 PRODUCT DRAWING(S): DWG-MD-2020339 SAFETY CHECK / SERVICE MANUAL(S): N/A SPECIFIC REQUIREMENT(S): SAMPLES WERE VISUALLY EVALUATED, AND IT WAS IMPOSSIBLE TO DETERMINE THE WHITE POWDER INSIDE THE FILTER. SCAN 20230817-1 WAS CREATED, AND SAMPLES WERE SENT TO THE SUPPLIER. THE SUPPLIER PALL MEDICAL CONDUCTED A FULL NC REVIEW, AND SENT SAMPLES TO SLS LAB, PALL NEWQUAY; AND NO ABNORMALITIES OR IMPURITIES WERE DETECTED DURING THE FILTER INSPECTION. EQUIPMENT / APPARATUS: N/A TEST RESULT(S): [ ] DEFECT CONFIRMED [X] DEFECT NOT CONFIRMED RESULTS DESCRIPTION: THE REPORTED DEFECT IS NOT CONFIRMED. SECTION D: RECORD REVIEW RELATED DSMS RECORDS IDENTIFIED: [ ] YES [X] NO [] N/A - NOT ENOUGH INFO FOR EVALUATION DSMS REPORT / CRITERIA: USA QM_11. DSMS RESULTS DESCRIPTION: N/A. EXISTING CAPA TO ADDRESS ISSUE?: [ ] YES [X] NO. PRODUCT PRODUCED BEFORE OR AFTER CORRECTIVE ACTION IMPLEMENTATION?: [ ] BEFORE [ ] AFTER [X] N/A DETAILS OF EXISTING CAPA: N/A. SECTION E: BATCH RECORD (BR) REVIEW: BR APPLICABILITY: [X] N/A - NOT REQUIRED [ ] APPLICABLE WERE ALL RELATED TEST RESULTS IN SPECIFICATION?: [ ] YES [ ] NO [X] N/A - NOT REQUIRED WERE ALL RELATED PROCESS PARAMETERS IN SPECIFICATION?: [ ] YES [ ] NO [X] N/A - NOT REQUIRED WERE ALL OPERATIONS COMPLETED AND DONE IN SEQUENCE?: [ ] YES [ ] NO [X] N/A - NOT REQUIRED EXPLAIN ANY "NO" ANSWERS: [X] N/A - NOT REQUIRED. SECTION F: INSPECTION & TESTING OF HOUSE RETAINS APPLICABILITY: [X] N/A - NOT REQUIRED [ ] APPLICABLE. SPECIFIC REQUIREMENT(S): N/A EQUIPMENT / APPARATUS: N/A TEST RESULT(S): [ ] DEFECT CONFIRMED [ ] DEFECT NOT CONFIRMED. [X] N/A - NOT REQUIRED. RESULTS DESCRIPTION: [X] N/A - NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ACCORDING TO THE CUSTOMER, THE FILTERS THEY RECENTLY PURCHASED HAVE A POWDER IN THEM, WHICH DARKENS AS DRUG IS INFUSED AND THEY ARE ALSO PRECIPITATING. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839523 EXTENSION SET SET, ADMINISTRATION, INTRA FPA B BRAUN MEDICAL INC 0061873343 04046964298219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown