MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-11 for ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2 ASK-20608-ROP manufactured by Arrow Intl., Inc..
[23405598]
(b)(4). A visual, functional and dimensional inspection could not be performed as no sample was returned for analysis. No lot number was provided. 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 and needle with no relevant findings. The ifu for this product was reviewed as a part of this complaint investigation. The ifu for this product states "use extreme care to never adjust position of the needle while catheter tip is still advanced beyond tip of needle. " if the catheter is retracted against the needle bevel, it can lead the catheter to shear as the customer reported. A corrective action is not required at this time as the potential cause of difficulty threading the catheter could not be determined based upon the info provided and without the sample. Complaint verification testing could not be performed as no sample was returned for analysis. The potential cause of difficulty threading the catheter through the needle could not be determined based upon the info provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
[23405599]
A customer alleges having difficulty in removing the needle and stylet. The catheter sheared and had to be restarted. No pt injury reported. Procedure - total knee replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00322 |
| MDR Report Key | 4999154 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-11 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2015-07-17 |
| Date Added to Maude | 2015-08-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MLL 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 | 0 |
| Brand Name | ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2 |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2015-08-11 |
| Catalog Number | ASK-20608-ROP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-08-11 |