BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
Report
- Report Number
- 3002601200-2025-00091
- Event Type
- Malfunction
- Date Received
- March 4, 2025
- Date of Event
- February 9, 2025
- Report Date
- April 3, 2025
- Manufacturer
- BD SUZHOU (MDS)
- Product Code
- FOZ
- UDI-DI
- 00382903830190
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
1. DHR/BHR REVIEW LOT#: 4145154. 1. THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JUN 2024, AND PACKAGED AT R240 & CFS PACKAGE LINE IN JUN 2024. BATCH SIZE IS (B)(4) EA. 2. IN THIS BATCH, 400 PCS WERE PERFORMED SEPTUM LEAKAGE TEST IN-PROCESS TEST AND 32 PCS IN OUTGOING TEST, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4. SEPTUM BATCHES USED IN THIS BATCH ARE 4141840, REVIEW THE RAW MATERIAL INSPECTION RECORDS, DIMENSION AND APPEARANCE HAVE NO ABNORMALITIES, WHICH BOTH MEET SPECIFICATION 2. THE CUSTOMER RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLES. THE PHOTO SHOWED THE BD PRODUCT IN USE HAS A SPECIFICATION OF 22GA AND NO DEFECTS HAVE BEEN FOUND IN THE COMPLAINT. 3. PERFORMED SEPTUM LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. 4. POSSIBLE CAUSES: 1. AFTER THE NEEDLE IS PIERCED INTO THE VEIN, THERE IS BLOOD AT THE NOTCH OF THE NEEDLE. IN THE PROCESS OF NEEDLE REMOVAL, ALTHOUGH THE PERFORATION OF THE SEPTUM IS CLOSED, THE BLOOD DROPS IN THE NOTCH WILL BE BROUGHT OUT WITH THE NOTCH. IF THERE IS A LOT OF INERTIA IN THE NEEDLE REMOVAL PROCESS, BLOOD DROPS WILL BE THROWN OUT. 2. IF THE PATIENT'S ARM IS TIED TIGHT DURING THE PUNCTURE, IT WILL CAUSE GREAT PRESSURE IN THE VEIN, AND BLOOD WILL COME OUT WITH THE NEEDLE WHEN THE NEEDLE IS PULLED OUT, BUT THE SUBSEQUENT BLOOD LEAKAGE WILL NOT BE SUSTAINED. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED, THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.
IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM LEAKAGE AT SEPTUM AT 14:00 ON (B)(6) 2025, THE PATIENT BOOKED AN APPOINTMENT FOR CRANIAL NUCLEAR MAGNETIC ENHANCEMENT EXAMINATION, ROUTINE PUNCTURE BEFORE THE EXAMINATION RETAINED 22-GAUGE INTRAVENOUS INDWELLING NEEDLE, PUNCTURE BEFORE THE SALINE TEST FLUSHING TUBE TO CHECK THE LEAKAGE OF DRIPS, PUNCTURE SUCCESSFULLY INTERMITTENT BACK TO THE BLOOD INJECTION WAS FOUND TO HAVE A SMALL AMOUNT OF REDDISH BLOODY FLUID FROM THE END OF THE NEEDLE WHITE ISOLATION PLUG OOZING, DUE TO THE PATIENT FOR THE TUMOR PATIENTS, VASCULAR CONDITIONS ARE POOR, ONLY ONE SIDE OF THE ARM CAN BE PUNCTURE, AND THEN DISINFECTED THE NEEDLE AS THE PATIENT WAS A TUMOR PATIENT WITH POOR VASCULAR CONDITION, ONLY ONE ARM COULD BE PUNCTURED, SO THE NEEDLE WAS STERILIZED AND THE STERILE HEPARIN CAP WAS SCREWED ON TO BLOCK THE LEAKAGE, AND AT THE SAME TIME, THE TECHNICIAN REPORTED TO THE DOCTOR TO ENHANCE THE TOTAL AMOUNT OF CONTRAST AGENT INJECTED WITHOUT BEING AFFECTED, AND IT WAS REMOVED AFTER THE COMPLETION OF THE EXAMINATION AND 30 MINUTES OF OBSERVATION.
NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436835 | BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM | INTRAVASCULAR CATHETER | FOZ | BD SUZHOU (MDS) | 4145154 | 00382903830190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |