EPIDURAL CATHETERIZATION KIT NRFIT
Report
- Report Number
- 3006425876-2024-00883
- Event Type
- Malfunction
- Date Received
- September 10, 2024
- Date of Event
- August 21, 2024
- Report Date
- August 21, 2024
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- BSO
- UDI-DI
- 10801902196788
- PMA / PMN Number
- K140110
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). THE REPORTED COMPLAINT OF THE EPIDURAL NEEDLE NOT CONNECTING TO THE SYRINGE WAS CONFIRMED BASED ON THE INVESTIGATION OF THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE EPIDURAL NEEDLE NRFIT, ONE 10ML PLASTIC LOR SYRINGE, AND LIDSTOCK. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT EPIDURAL NEEDLE IS TYPICAL, AND THE LOR SYRINGE IS A LUER FIT CONNECTION. THE REPORTED KIT (TU-05500-NRO) TYPICALLY IS PACKAGED WITH AN LOR SYRINGE NRFIT CONNECTION (KZ-05501-002N). HOWEVER, IT WAS PACKAGED WITH LOR SYRINGE KZ-05501-002 LUER CONNECTION INSTEAD. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON EPIDURAL KIT WITH NO RELEVANT FINDINGS. HOWEVER, BASED ON THE SAMPLE RECEIVED, THE POTENTIAL ROOT CAUSE OF THIS COMPLAINT ISSUE IS PACKAGING RELATED. FURTHER INVESTIGATION HAS BEEN INITIATED UNDER TELEFLEX QUALITY SYSTEM TO EVALUATE THIS ISSUE.
IT WAS REPORTED THAT: "THE EPIDURAL NEEDLE COULD NOT BE CONNECTED TO THE SYRINGE DURING USE. THEREFORE, A NEW KIT WAS USED INSTEAD."
IT WAS REPORTED THAT: "THE EPIDURAL NEEDLE COULD NOT BE CONNECTED TO THE SYRINGE DURING USE. THEREFORE, A NEW KIT WAS USED INSTEAD.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2331110 | EPIDURAL CATHETERIZATION KIT NRFIT | ANESTHESIA CONDUCTION CATHETER | BSO | ARROW INTERNATIONAL LLC | 71F23F0740 | 10801902196788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED.| NOT REPORTED. |