MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-18 for ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS, OPEN TIP SINGLE-PORT CATHE manufactured by Arrow International.
[43295771]
We have used the arrow epidural catheterization kit for a number of years without incident or problem; however, recently we have noted the epidural catheter included in the kit is more elastic, stretching to the point of breakage; and has resulted in one breakage to date. Arrow epidural catheterization kit with flextip plus, open tip single-port catheter; (b)(6) 2016 inserted by crna for pain control during vaginal delivery. Break during removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061812 |
| MDR Report Key | 5593451 |
| Date Received | 2016-04-18 |
| Date of Report | 2016-04-18 |
| Date of Event | 2016-04-14 |
| Date Added to Maude | 2016-04-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS, OPEN TIP SINGLE-PORT CATHE |
| Generic Name | EPIDURAL KIT |
| Product Code | OFT |
| Date Received | 2016-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL |
| Manufacturer Address | READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-18 |