MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-07-10 for ARROW EPIDURAL CATHETERIZATION COMPONENT EC-05500 manufactured by Arrow International Inc..
[6069914]
The customer alleges that the anesthesiologist could not flush the catheter. The catheter was replaced without issue. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13973497]
(b)(4). The investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[23940516]
(b)(4). The customer returned an epidural catheter, a snaplock adapter, and a 10ml injection syringe for investigation. The returned injection syringe is not a component contained in the reported product code. A visual exam was performed and no defects were observed. Functional testing was also performed and no blockages were found. No lot number was provided by the customer; therefore, a device history record (dhr) review was performed based on a lot number from the sales history of the customer. The reported complaint of a blocked catheter was not confirmed based on the sample received. A dhr review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue. There were no functional issues found with the returned sample.
Patient Sequence No: 1, Text Type: N, H10
[23940517]
The customer alleges that the anesthesiologist could not flush the catheter. The catheter was replaced without issue. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00298 |
| MDR Report Key | 4905534 |
| Report Source | 05,06,07 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-06-29 |
| Date of Event | 2015-05-22 |
| Date Mfgr Received | 2015-07-30 |
| Date Added to Maude | 2015-07-10 |
| 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 | 0 |
| Event Location | 0 |
| 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 EPIDURAL CATHETERIZATION COMPONENT |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2015-07-10 |
| Returned To Mfg | 2015-07-11 |
| Catalog Number | EC-05500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-10 |