BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
Report
- Report Number
- 3002601200-2025-00003
- Event Type
- Malfunction
- Date Received
- January 17, 2025
- Date of Event
- December 18, 2024
- Report Date
- May 6, 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.
A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A RETAIN SAMPLE ANALYSIS COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE AND BATCH/LOT NUMBER INFORMATION.
1. THE CUSTOMER RETURNS NOT THE ACTUAL SAMPLE. IT CAN BE RECOGNIZED FROM THIS PHOTO THAT THE NOTCH OF THE NEEDLE CORE IS SLIGHTLY DARK IN COLOR, AND THE RUST OF THE NEEDLE CORE IS NOT RECOGNIZED. 2. DHR/BHR REVIEW LOT#1020006 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN FEB 2021, AND PACKAGED AT R240 PACKAGE LINE IN FEB 2021. 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. 4-THE CANNULA BATCH USED IN THIS BATCH OF PRODUCTS IS 0309667 AND 0352508, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN, AND THE NEEDLE CORES ARE EXAMINED UNDER THE MICROSCOPE. NO RUST IS FOUND. PLEASE SEE ATTACHMENT FOR THE PHOTOS. 4. CAUSE ANALYSIS: 1-THE NEEDLE CORE IS MADE OF 304 STAINLESS STEEL AND LUBRICATED BY SILICONE, WHICH HAS GOOD RUST RESISTANCE UNDER NORMAL CIRCUMSTANCES, BUT UNDER SPECIAL CONDITIONS (SUCH AS IN THE AIR CONTAINING CHLORINATED CHEMICALS), THE HEAD OF THE NEEDLE CORE MAY RUST. THE PLANT DOES NOT HAVE THE CONDITIONS TO CAUSE THE DEFECT IN THE PRODUCTION PROCESS. 2-THE NOTCH OF THE NEEDLE CORE IS WRAPPED IN THE CATHETER, AND RUST HAS NEVER OCCURRED. THE SLIGHTLY DARK COLOR OF THE NOTCH IS RELATED TO THE PRODUCTION PROCESS OF THE NEEDLE CORE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND THIS BATCH IS PRODUCED IN FEB 2021, WHICH IS EXCEEDED THREE YEARS EXPIRATION CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS AND THIS BATCH IS EXCEEDED THREE YEARS EXPIRATION SO THE ROOT CAUSE OF THE RUST OF THE NEEDLE CANNOT BE DETERMINED.
IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM HAD RUST / CORROSION. PATIENT YEAR ON (B)(6) GIVEN TO REPLACE THE INDWELLING NEEDLE AFTER SUCCESSFUL PUNCTURE RESISTANCE WHEN RETREATING THE NEEDLE, PREGNANT WOMEN INFUSION IS NOT SMOOTH, AFTER ASSESSMENT GIVEN TO REPLACE THE INDWELLING NEEDLE, INDWELLING NEEDLE AFTER SUCCESSFUL PUNCTURE ROUTINELY RETREATING THE STEEL NEEDLE WHEN FEELING A SIGNIFICANT RESISTANCE TO CARRY OUT AN INVESTIGATION FOUND THAT THE INDWELLING NEEDLE NEEDLE EYE WITH RUST STAINS, PACIFY THE PREGNANT WOMEN GIVEN TO REPLACE THE INDWELLING NEEDLE.
NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016702 | BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM | INTRAVASCULAR CATHETER | FOZ | BD SUZHOU (MDS) | UNKNOWN | 00382903830190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |