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 2015-03-09 for ARROW CONTINUOUS NERVE BLOCK KIT FB-19608-K manufactured by Arrow Intl., Inc..
[5466143]
The customer alleges that the catheter was hard to thread. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13003012]
Qn#(b)(4). A visual, functional and dimensional inspection was performed on the returned sample. A device history record review was performed on the epidural needle and the epidural catheter with no relevant findings. A corrective action is not required at this time as the returned sample functioned properly after biological material was removed from the needle. The condition of the sample returned indicates that operational context caused or contributed to this event. The reported complaint of difficulty threading and removing the catheter from the epidural needle was confirmed based on the sample received. The catheter could be threaded through the epidural needle. However, due to excessive dried biological material in the needle cannula, resistance was met. After some of the biological material was removed from the needle cannula, the catheter could be thread with less resistance and the components passed a functional drag test. The id of the needle was measured and found to be within specification. A device history record review was performed on the epidural needle and catheter with no evidence to suggest a manufacturing related cause. Based on the condition of the sample received and the information provided, operational context caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00054 |
| MDR Report Key | 4602845 |
| Report Source | 05,06,07 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-02-12 |
| Date of Event | 2015-01-13 |
| Date Mfgr Received | 2015-02-12 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-04-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | ARROW INTL., INC. |
| Manufacturer Street | 312 COMMERCE PL. |
| 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 CONTINUOUS NERVE BLOCK KIT |
| Product Code | OGJ |
| Date Received | 2015-03-09 |
| Returned To Mfg | 2015-02-20 |
| Catalog Number | FB-19608-K |
| Lot Number | 23F14F0872 |
| Device Expiration Date | 2015-11-30 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTL., INC. |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-09 |