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 2015-04-22 for ARROW CONTINUOUS NERVE BLOCK SET AB-19604-S manufactured by Arrow Intl., Inc..
[5744033]
The event is reported as: the customer alleges that the catheter was difficult to remove from a (b)(6) yr old male pt. The catheter was inserted into the pt with no issue, however, the pt went to the emergency room (er) later when he began to experience paresthesia down his arm. The er physician attempted to remove the catheter and was unsuccessful. Intervention: the physician who inserted the catheter into the pt, dr (b)(6) was called to remove the catheter and was unsuccessful after attempting to reposition the pt. After the catheter was viewed on an x-ray, the goal was to remove the catheter by performing an ultrasound with 2 injections of 40ml of saline, however, the catheter still could not be removed. After a surgical consultation it was decided that surgery was unnecessary and the catheter was successfully removed with a catheter central line introducer.
Patient Sequence No: 1, Text Type: D, B5
[13172162]
At this time, it is unk if the sample is available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00144 |
| MDR Report Key | 4723233 |
| Report Source | 05,06,07 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-03-29 |
| Date of Event | 2015-03-29 |
| Date Mfgr Received | 2015-03-29 |
| Date Added to Maude | 2015-06-03 |
| 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 | WARRENDA PETERSON, QUAL COMPLAINTS |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193613959 |
| 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 | ANESTHESIA NERVE BLOCK SET |
| Product Code | OGJ |
| Date Received | 2015-04-22 |
| Catalog Number | AB-19604-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 | 2015-04-22 |