MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2015-07-09 for ARROW CONTINUOUS NERVE BLOCK KIT AB-05060-PK manufactured by Arrow International Inc..
[6535937]
The customer alleges that after advancing the catheter, the anesthesiologist withdrew the catheter to reposition needle and the outer coating of the catheter sheared and the wire uncoiled. The catheter was removed and replaced with another catheter without incident. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13771419]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[23939638]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the catheter was separated at the distal end. The distal coil wire was unraveled and the distal ball weld was not present. It was also noticed that the extrusion at the distal end was stretched. The stylet appeared typical with no observed defects. The instructions for use for this product warns the customer, "never adjust the position of the needle while catheter tip is still advanced beyond the needle tip. If resistance is encountered when retracting catheter into needle, remove needle and catheter as a unit from patient and repeat procedure. Forcefully pulling back on catheter may result in catheter breakage. " based on the investigation performed, the reported complaint was confirmed. The bulleted tip of the coil wire was confirmed to have separated from the returned catheter and the piece was not returned. A dhr review was performed on the catheter with no evidence to suggest a manufacturing related cause. A corrective action is not required at this time as the complainant reported that "the anesthesiologist withdrew the catheter to reposition the needle and sheared the catheter resulting in the coils unraveling", which indicates that use error caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[23939639]
The customer alleges that after advancing the catheter, the anesthesiologist withdrew the catheter to reposition needle and the outer coating of the catheter sheared and the wire uncoiled. The catheter was removed and replaced with another catheter without incident. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00297 |
| MDR Report Key | 4902593 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-08-04 |
| Device Manufacturer Date | 2014-01-08 |
| Date Added to Maude | 2015-07-09 |
| 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 | 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 | 2015-07-09 |
| Returned To Mfg | 2015-07-16 |
| Catalog Number | AB-05060-PK |
| Lot Number | 23F14A0548 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-07-09 |