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 2014-11-21 for ARROW CONTINUOUS NERVE BLOCK KIT AB-19608-KS manufactured by Arrow International Inc.
[5272146]
The customer alleges that after successful insertion and after the pt left the facility the catheter was ripped/yanked out of the interscalene block. It is unk how the event occurred at this time. Per the doctor, upon inspection of the catheter, the distal tip is missing and possibly inside the pt. The pt had an x-ray taken to verify. Per sales rep. , the x-ray came back negative for the retained device.
Patient Sequence No: 1, Text Type: D, B5
[12591586]
(b)(4). A visual and photo inspection was conducted. The distal tip of catheter cannot be seen from photo. Visual examine of device revealed used catheter with adhesive residue present. The centimeter markers of catheter are worn and have no exposed coil at proximal or distal end. The returned catheter appears shorter than the lab inventory catheter, indicating at least 3. 131 cm of catheter is missing. The returned catheter appears stretched at the distal end. No lot number provided. A dhr was performed on rep lot number and no relevant findings were observed. The ifu states to never tug or pull quickly on the catheter during removal so as to minimize the risk of catheter breakage. A corrective action is not required, at this time, as the damage observed and the info provided indicates that the use error caused or contributed to this event. The reported complaint of a missing distal tip was confirmed based on the condition of the sample and info provided. The use error caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00457 |
| MDR Report Key | 4293245 |
| Report Source | 05,06,07 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-10 |
| Date of Event | 2014-11-10 |
| Date Mfgr Received | 2014-11-10 |
| Date Added to Maude | 2014-12-04 |
| 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 | MARGIE BURETON, RN, REGULATORY A |
| Manufacturer Street | 3015 CARRINGTON MILL 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 | 3 |
| Brand Name | ARROW CONTINUOUS NERVE BLOCK KIT |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2014-11-21 |
| Returned To Mfg | 2014-11-12 |
| Catalog Number | AB-19608-KS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC |
| Manufacturer Address | 312 COMMERCE PL ASHEBORO NC 27203 US 27203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |