EPIDURAL CATHETERIZATION SET NRFIT
Report
- Report Number
- 3006425876-2022-00508
- Event Type
- Malfunction
- Date Received
- May 25, 2022
- Date of Event
- May 16, 2022
- Report Date
- May 16, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- CAZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.
(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED DIFFICULTY INSERTING THE CATHETER INTO THE PATIENT. THE CUSTOMER RETURNED ONE EPIDURAL CATHETER. NO EPIDURAL NEEDLE WAS RETURNED. THE RETURNED CATHETER WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THE CATHETER APPEARS USED. BIOLOGICAL MATERIAL CAN BE SEEN BETWEEN THE INNER COILS. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL CATHETER. THE OUTER DIAMETER (OD) OF THE RETURNED CATHETER MEASURED 1.06MM (CALIPER: REF-003210) WHICH IS WITHIN THE SPECIFICATION OF A MAXIMUM OF 1.115MM PER GRAPHIC KZ-05400-030; REV 5. A FUNCTIONAL TEST WAS PERFORMED BY ATTEMPTING TO THREAD THE RETURNED CATHETER THROUGH A LAB INVENTORY EPIDURAL NEEDLE. THE CATHETER WAS THREADED AT THE DISTAL END AND WOULD THREAD THROUGH THE EPIDURAL NEEDLE WITH NO RESISTANCE MET. A DRAG TEST WAS PERFORMED PER PIP-013; REV 5 USING THE RETURNED CATHETER, A LAB INVENTORY NEEDLE, AND A WEIGHT (REF-002579). THE RETURNED CATHETER COULD THREAD THROUGH THE LAB INVENTORY NEEDLE WITH NO RESISTANCE MET. THE RETURNED CATHETER AND LAB INVENTORY NEEDLE PASSED THE DRAG TEST. SPECIFICATIONS PER GRAPHIC KZ-05400-030; REV 5 WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05400-030 AND JZ-05500-004N AS A PART OF THIS COMPLAINT INVESTIGATION. THERE HAVE BEEN NO MATERIAL CHANGES FOR THESE PARTS DURING THE LAST TWO YEARS THAT COULD HAVE LED TO THIS COMPLAINT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND THE SAMPLE RECEIVED. THE REPORTED COMPLAINT OF DIFFICULTY INSERTING THE CATHETER INTO THE PATIENT COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE EPIDURAL CATHETER. HOWEVER, THE EPIDURAL NEEDLE WAS NOT RETURNED. THE RETURNED CATHETER COULD BE THREADED THROUGH A LAB INVENTORY NEEDLE WITH NO RESISTANCE MET. THE RETURNED CATHETER PASSED A FUNCTIONAL DRAG TEST, AND THE RETURNED CATHETER OD WAS FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND EPIDURAL NEEDED WITH NO RELEVANT FINDINGS. HOWEVER, THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND THE SAMPLE RECEIVED. NO FURTHER ACTION IS REQUIRED AT THIS TIME.
THE USER FELT A RESISTANCE WHEN INSERTING THE CATHETER TO THE PATIENT. THEREFORE, HE/SHE USED A NEW CATHETER FROM ANOTHER KIT, WHICH COULD BE INSERTED. ANOTHER NEEDLE PUNCTURE WAS PERFORMED AND A NEW CATHETER WAS SUCCESSFULLY INSERTED.
THE USER FELT A RESISTANCE WHEN INSERTING THE CATHETER TO THE PATIENT. THEREFORE, HE/SHE USED A NEW CATHETER FROM ANOTHER KIT, WHICH COULD BE INSERTED. ANOTHER NEEDLE PUNCTURE WAS PERFORMED AND A NEW CATHETER WAS SUCCESSFULLY INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 889497 | EPIDURAL CATHETERIZATION SET NRFIT | CAZ | ARROW INTERNATIONAL LLC | 71F21K0666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | N/A. |