MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2015-07-23 for ARROW SPINAL ANES/EPIDURAL CATH KIT UI-05502 manufactured by Arrow International Inc..
[21057379]
The customer alleges that after inserting the epidural catheter, the physician was unable to administer medication through the catheter and it was not patent. The physician had to insert another epidural.
Patient Sequence No: 1, Text Type: D, B5
[21378005]
(b)(4). Note - voluntary report no: mw5042250, as reported on the maude event report. It is unknown if the device sample is available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[23937054]
(b)(4). Note - voluntary report no: (b)(4), as reported on the maude event report. A device history record (dhr) review was performed on the epidural catheter with no relevant findings. Complaint verification testing could not be performed as no sample was returned for analysis. A dhr review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of difficulty injecting through the epidural catheter could not be determined based upon the information provided and without a sample. If the sample is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[23937055]
The customer alleges that after inserting the epidural catheter, the physician was unable to administer medication through the catheter and it was not patent. The physician had to insert another epidural.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00284 |
| MDR Report Key | 4936538 |
| Report Source | 00,OTHER |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-01-24 |
| Date Mfgr Received | 2015-08-19 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-07-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW SPINAL ANES/EPIDURAL CATH KIT |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2015-07-23 |
| Catalog Number | UI-05502 |
| Lot Number | 23F14K0049 |
| Device Expiration Date | 2016-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-23 |