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 2015-05-22 for ARROW CONTINUOUS NERVE BLOCK SET AB-20608-S manufactured by Arrow International Inc..
[5816436]
The customer alleges that the stimucath was in place for four days. After completion of the therapy, during removal of the catheter, it seems as if the catheter was "firmly grown", and resistance was felt. Soft force was applied in order to remove the catheter causing the catheter to dissolve into parts. The catheter was removed in its entirety. No patient complications. No patient injury reported
Patient Sequence No: 1, Text Type: D, B5
[13302969]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[23946483]
(b)(4). The catheter was returned for evaluation. A visual exam was performed and it was found to be separated. The customer indicated that the catheter was in use for four days. This product is only indicated for use up to 72 hours. The returned catheter also showed signs of severe stretching and the catheter's safety ribbon was separated which indicates that the catheter was pulled on with excessive force. No lot number was provided by the customer; therefore, a device history record (dhr) review was performed based on a lot number from the customer sales history. There were no relevant findings. The reported complaint of difficult removing the catheter was confirmed based on the sample received. Based on the information provided and the condition of the sample received, it was determined that user error caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[23946484]
The customer alleges that the stimucath was in place for four days. After completion of the therapy, during removal of the catheter it seems as if the catheter was "firmly grown" and resistance was felt. Soft force was applied in order to remove the catheter causing the catheter to dissolve into parts. The catheter was removed in its entirety. No patient complications. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00195 |
| MDR Report Key | 4794853 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-08 |
| Date of Event | 2015-05-05 |
| Date Mfgr Received | 2015-06-02 |
| Date Added to Maude | 2015-06-18 |
| 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 CONTINUOUS NERVE BLOCK SET |
| Generic Name | NERVE BLOCK KIT |
| Product Code | OGJ |
| Date Received | 2015-05-22 |
| Returned To Mfg | 2015-05-20 |
| Catalog Number | AB-20608-S |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-22 |