MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-03-03 for ARROW CONTINUOUS NERVE BLOCK SET AB-20608-S manufactured by Arrow Intl., Inc..
[5476992]
The customer alleges that during removal the catheter separated and could not be removed. Intervention - the patient was monitored and sedated in an attempt to remove the device. Removal was successful. No further harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[13067223]
(b)(4). The investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00066 |
| MDR Report Key | 4570366 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-03-03 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-01-15 |
| Date Mfgr Received | 2015-02-06 |
| Date Added to Maude | 2015-04-06 |
| 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 | MARGIE BURTON |
| 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 SET |
| Generic Name | NERVE BLOCK SET |
| Product Code | OGJ |
| Date Received | 2015-03-03 |
| Catalog Number | AB-20608-S |
| 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 INTL., INC. |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-03 |