BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 22015450 · Received May 13, 2025

    Report

    Report Number
    3006948883-2025-00135
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    March 7, 2025
    Report Date
    June 5, 2025
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW (LOT#4243812): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEP 2024, AND PACKAGED AT R240 PACKAGE LINE IN SEP 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2)REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO DEFECTIVE SAMPLE AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO BLACK FOREIGN MATTER VISIBLE ON THE NEEDLE TIP ARE FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES. SINCE WE HAVE NOT RECEIVED THE DEFECTIVE SAMPLE, WE CANNOT CONFIRM THE STATUS AND COMPOSITION OF THE FOREIGN MATTER, SO THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO MONITOR SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II 24GAX0.75IN PRN SLM HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: DATE OF VISIT: (B)(6) 2025 11:38:44. DEPARTMENT: PEDIATRICS CHIEF COMPLAINT: COUGHING AND NASAL CONGESTION FOR 3 DAYS, FEVER FOR HALF A DAY. PRESENT ILLNESS: THE PATIENT DEVELOPED COUGHING 3 DAYS AGO, PRESENTING AS PAROXYSMAL NON-SPASMODIC COUGHING WITH PHLEGM, ACCOMPANIED BY NASAL CONGESTION AND RHINORRHEA. OUTPATIENT TREATMENT WAS ADMINISTERED WITH ¿CEFUROXIME AND PEDIATRIC ACETAMINOPHEN AND CHLORPHENIRAMINE GRANULES¿ ORALLY. HALF A DAY AGO, THE PATIENT DEVELOPED FEVER, WITH NO SPECIFIC TEMPERATURE RECORDED. THE PATIENT WAS ADMINISTERED ¿IBUPROFEN SUSPENSION¿ ORALLY, WHICH REDUCED THE FEVER, BUT IT RECURRED EASILY. BOWEL MOVEMENTS AND URINATION WERE NORMAL. PHYSICAL EXAMINATION: GENERAL CONDITION SLIGHTLY POOR, ALERT, PHARYNX CONGESTED, BILATERAL TONSILS SWOLLEN TO DEGREE II, WITH PURULENT SECRETIONS VISIBLE, BILATERAL LUNG AUSCULTATION WITH COARSE BREATH SOUNDS, NO RALES, ABDOMEN FLAT AND SOFT, UMBILICAL REGION TENDER, NO REBOUND TENDERNESS, BOWEL SOUNDS NORMAL. DIAGNOSIS: ACUTE BRONCHITIS, ACUTE SUPPURATIVE TONSILLITIS. TREATMENT AND MANAGEMENT: PARENTS REQUESTED INTRAVENOUS TREATMENT AND FOLLOW-UP CONSULTATION IF NECESSARY. AT 12:12, THE NURSE ON DUTY FOUND A BLACK FM VISIBLE ON THE NEEDLE TIP WHILE PREPARING AN INTRAVENOUS CANNULA FOR OUTPATIENT (B)(6). SHE IMMEDIATELY REPLACED IT WITH A NEW, UNOPENED, SEALED INTRAVENOUS CANNULA, COMPLETED THE INFUSION, AND REPORTED THE ADVERSE EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881685 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 4243812 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown