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 2014-07-03 for ARROW STIMUCATH SET: 19G CATH, 17G X 9CM NDL AN=B-05060 manufactured by Arrow Intl., Inc..
[21880592]
The event is reported as: the customer alleges that the catheter would not come out when the patient tried to remove it. The patient went to the emergency room to have it removed. The catheter was removed successfully in its entirety. No patient injury or consequence reported.
Patient Sequence No: 1, Text Type: D, B5
[22148084]
The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00273 |
| MDR Report Key | 4015016 |
| Report Source | 05,06,07 |
| Date Received | 2014-07-03 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-06-14 |
| Date Mfgr Received | 2014-06-16 |
| Date Added to Maude | 2014-08-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| 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 STIMUCATH SET: 19G CATH, 17G X 9CM NDL |
| Generic Name | NERVE BLOCK KIT |
| Product Code | OGJ |
| Date Received | 2014-07-03 |
| Catalog Number | AN=B-05060 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-03 |