BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
Report
- Report Number
- 3006948883-2026-00001
- Event Type
- Malfunction
- Date Received
- January 9, 2026
- Date of Event
- December 13, 2025
- Report Date
- March 3, 2026
- Manufacturer
- BD SUZHOU (MDS)
- Product Code
- FOZ
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTION: MATERIAL # CORRECTED IN THE EVENT DESCRIPTION (SECTION B5); FROM 3830097 TO 383097. ADDITIONAL INFORMATION: SECTION D - MEDICAL DEVICE LOT # UPDATED AND MEDICAL DEVICE EXPIRATION DATE ADDED. SECTION H - DEVICE MANUFACTURE DATE ADDED. INVESTIGATION RESULTS: 1. THE CUSTOMER RETURNED 3 PHOTOS AND 1 VIDEO BUT DID NOT RETURN THE COMPLAINT UNITS. THE PHOTOS AND VIDEO SHOW THAT THE SEPTUM OF THE UNITS HAS DISLODGED, CAUSING THE ADHESIVE INJECTION HOLE OF THE CATHETER HUB TO BE EXPOSED AND LEAKING. 2. DHR/BHR REVIEW (LOT#5093665): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2025 AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2025. WORK ORDER QUANTITY WAS (B)(4) PCS. 2) THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) THE LEAKAGE TEST RESULTS OF 160PCS IN PROCESS TESTING AND 32PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS. 4) NO UNQUALIFIED DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS. 5) THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. FUNCTIONAL TEST (LEAKAGE TEST) WAS CONDUCTED ON A RETAINED SAMPLE OF THE COMPLAINED BATCH, THE TEST PASSED, AND NO ABNORMALITY WAS FOUND IN THE SAMPLE. 4. CAUSE ANALYSIS: 1) THE SEPTUM AND THE CATHETER HUB ARE BONDED BY UV ADHESIVE. AFTER THE ADHESIVE IS DRIED, THE VISUAL INSPECTION SYSTEM CONDUCTS 100% INSPECTION, WHICH WILL AUTOMATICALLY IDENTIFY AND REMOVE DEFECTIVE PRODUCTS. THE VISUAL INSPECTION SYSTEM IS CHALLENGED WITH STANDARD SAMPLES EVERY 12 HOURS AND WHEN CHANGING PRODUCT GAUGE TO ENSURE THE EFFECTIVENESS OF THE INSPECTION. 2) THE DISPLACEMENT OF THE SEPTUM MAY BE CAUSED BY VARIOUS FACTORS: THE OUTER DIAMETER OF THE SEPTUM, THE INNER DIAMETER OF THE CATHETER SEAT, INSUFFICIENT ADHESIVE APPLIED TO THE SEPTUM, CONTAMINATION OF THE SEPTUM WITH LUBRICANT (A SOLVENT CONTAINING MEDICAL-GRADE SILICONE OIL), AND VARIATIONS IN THE RAW MATERIAL OF THE SEPTUM, ALL OF WHICH CAN AFFECT THE SEALING PERFORMANCE OF THE PRODUCT. CONCLUSION(S): NO ABNORMALITY WAS FOUND ON PROCESS AND RETAINED SAMPLE. FROM THE PHOTOS AND VIDEO, IT IS IDENTIFIED THAT THE LEAKAGE IS DUE TO THE DISLODGEMENT OF THE SEPTUM. THE DISPLACEMENT OF THE SEPTUM MAY BE CAUSED BY VARIOUS FACTORS, BUT SINCE THE COMPLAINT UNITS WERE NOT RETURNED, THE RELEVANT TESTING COULD NOT BE CONDUCTED, SO THE ROOT CAUSE OF THE SEPTUM DISPLACEMENT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO MONITOR AND PERFORM TREND ANALYSIS ON THIS TYPE OF DEFECT.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
ON (B)(6) 2025, THE EMERGENCY DEPARTMENT AT (B)(6) HOSPITAL REPORTED A CASE WHERE BLOOD LEAKED FROM A 383097 INDWELLING NEEDLE AFTER HIGH-PRESSURE INJECTION, AND THE ISOLATION PLUG WAS RETURNED. TWO ADDITIONAL CASES OCCURRED ON (B)(6).
IT WAS REPORTED THAT BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP LEAKED WITH POWER INJECTOR ON (B)(6) 2025. THE EMERGENCY DEPARTMENT AT (B)(6) REPORTED A CASE WHERE BLOOD LEAKED FROM A 3830097 INDWELLING NEEDLE AFTER HIGH-PRESSURE INJECTION, AND THE ISOLATION PLUG WAS RETURNED. TWO ADDITIONAL CASES OCCURRED ON THE 13TH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331133 | BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP | INTRAVASCULAR CATHETER | FOZ | BD SUZHOU (MDS) | 5093665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |