MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-06-19 for ARROW CONTINUOUS NERVE BLOCK KIT AB-19608-K manufactured by Arrow International Inc..
[5873194]
The customer reports that the patient complained of leg pain and skin excoriation that turned out to be the catheter. It appeared that the wire strand pierced through the catheter. The patient's skin was irritated and the catheter was removed. No report of patient injury/harm.
Patient Sequence No: 1, Text Type: D, B5
[13373540]
(b)(4). A visual, functional and dimensional inspection could not be performed as no sample was returned by the customer for investigation. No lot number was provided by the customer. A device history record review was performed based on a lot number from sales history data. A device history record review was performed on the catheter with no relevant findings. A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. No lot number was provided by the customer. A device history record review was performed based on a lot number from sales history. A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of coil wire pierced through the catheter extrusion could not be determined based upon the information provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
[23945293]
(b)(4). The customer returned one catheter for evaluation. A visual exam was performed and it was observed that the extrusion of the catheter was stretched. The distal ball weld was present and intact. The returned catheter was found to have the coil wire protruding the extrusion at approximately 74mm from the proximal end of the catheter. Also, holes in the extrusion were observed at approximately 27mm and 34mm from the proximal end of the catheter. Functional testing was performed and leaks could be seen from the sites where the coil wire protrudes the extrusion and where there were holes in the extrusion. No lot number was provided by the customer; therefore, a device history record (dhr) was performed based on a lot number from the sales history of the customer. Based on the investigation performed, the reported complaint of a coil wire piercing through the catheter was confirmed. A dhr review was performed on the catheter with no evidence to suggest a manufacturing related cause. Therefore, based on the condition of the sample received and the time of discovery, it was determined that operational context caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[23945294]
The customer reports that the patient complained of leg pain and skin excoriation that turned out to be the catheter. It appeared that the wire strand pierced through the catheter. The patient's skin was irritated and the catheter was removed. No report of patient injury/harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00234 |
| MDR Report Key | 4856311 |
| Report Source | 06,07 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-28 |
| Date of Event | 2015-05-22 |
| Date Mfgr Received | 2015-07-15 |
| Date Added to Maude | 2015-06-19 |
| 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 KIT |
| Generic Name | NERVE BLOCK KIT |
| Product Code | OGJ |
| Date Received | 2015-06-19 |
| Returned To Mfg | 2015-07-02 |
| Catalog Number | AB-19608-K |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-19 |