INTIMA-II 24GAX0.75IN PRN SLM NPVC
Report
- Report Number
- 3006948883-2025-00873
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- October 7, 2025
- Report Date
- November 21, 2025
- Manufacturer
- BECTON DICKINSON
- 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
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
1. DHR/BHR REVIEW (LOT#5132894): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JUN 2025 AND PACKAGED AT R240 PACKAGE LINE IN JUN 2025. 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. CUSTOMER RETURNED 1 PHOTO, NO ACTUAL SAMPLE. THE PHOTO SHOWS: THE NEEDLE TIP OF THE DEFECTIVE SAMPLE HAS WHITE FOREIGN MATTER ATTACHED. 3. CHECKED THE RETAINED SAMPLES OF THIS BATCH AND FOUND NO SIMILAR FOREIGN MATTER. 4. BASED ON THE ANALYSIS OF THE FOREIGN OBJECT IN THE RETURNED PHOTO, THE FOREIGN OBJECT MAY BE DEBRIS FROM THE PADDLE HUB. THE DEBRIS ORIGINATED FROM THE DISPENSING STATION IN ZONE 5 AND WAS CAUSED BY THE GRIPPER DAMAGING THE PADDLE HUB. 5. FOR THE PADDLE HUB DEBRIS GENERATED IN ZONE 5, MEASURES HAVE BEEN TAKEN TO INSTALL A VACUUM DEVICE BETWEEN ZONE 5 AND ZONE 7 TO SUCK UP THE PADDLE HUB DEBRIS. ADDITIONAL NEW MEASURES HAVE ALSO BEEN IMPLEMENTED: BEFORE EACH SHIFT STARTS, USE ALCOHOL WIPES TO CLEAN THE CLAMPS AND MACHINE SURFACES, REDUCING THE RESIDUE OF PADDLE HUB DEBRIS. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTO SHOWS FOREIGN MATTER ATTACHED TO THE NEEDLE TIP, BUT SINCE DEFECTIVE SAMPLE WAS NOT RECEIVED FOR RELEVANT TESTING, THE SPECIFIC COMPOSITION OF THE FOREIGN MATTER CANNOT BE DETERMINED, AND THEREFORE THE EXACT SOURCE OF THE FOREIGN MATTER CANNOT BE IDENTIFIED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.
ON THE NIGHT SHIFT OF (B)(6) 2025, A NURSE PREPARED FOR INTRAVENOUS INFUSION THERAPY ON A PREMATURE NEWBORN. AFTER COMPLETING SKIN DISINFECTION ACCORDING TO PROTOCOL, THE NURSE OPENED A SINGLE-USE CLOSED-SYSTEM INTRAVENOUS CATHETER (MODEL: 24G×0.75IN, LOT NO.: 5132894). DURING VERIFICATION PRIOR TO REMOVING THE NEEDLE CAP AND PERFORMING THE PUNCTURE, A VISIBLE BURR WAS OBSERVED AT THE TIP OF THE NEEDLE. TO ENSURE PATIENT SAFETY, THE DEVICE WAS IMMEDIATELY DISCARDED. A REPLACEMENT INDWELLING NEEDLE FROM THE SAME BATCH WAS SUCCESSFULLY USED TO COMPLETE THE PUNCTURE. NO MECHANICAL INJURY OR OTHER ADVERSE EFFECTS WERE CAUSED TO THE INFANT THROUGHOUT THE PROCESS. ADDITIONAL INFORMATION: IS THE BURR SUSPECTED TO BE A FOREIGN OBJECT OR CATHETER MATERIAL? CLINICAL FEEDBACK INDICATES VISUAL SUSPICION OF A FOREIGN OBJECT; CATHETER SHOWS NO DAMAGE. DID THE BURR ORIGINATE FROM THE STEEL NEEDLE OR THE FLEXIBLE CATHETER BODY? NO. WAS THE FLEXIBLE CATHETER PUNCTURED BY THE STEEL NEEDLE TIP? NO. WAS THE STEEL NEEDLE IN USE WHEN THE ISSUE WAS DISCOVERED? NO, THE FOREIGN OBJECT WAS FOUND IMMEDIATELY AFTER OPENING THE OUTER PACKAGING DOES THE CATHETER BODY SHOW SIGNS OF SEPARATION FROM THE STEEL NEEDLE? NO.
NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2362710 | INTIMA-II 24GAX0.75IN PRN SLM NPVC | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 5132894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |