MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-03-03 for ARROW CONTINUOUS NERVE BLOCK SET AB-20608-S manufactured by Arrow International Inc..
[16076342]
The customer alleges that during removal of the catheter high force was required. The tip of the removed catheter was uncoiled. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[16387952]
(b)(4). The investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[71852568]
(b)(4). The customer returned one catheter piece for investigation. The entire catheter was not returned. A visual exam was performed and it was observed that the catheter was separated after the 13 cm marker band. The distal tip was present. The catheter was cut at the proximal end as the coils and extrusion were not stretched at the point of separation. The distal ball weld was present and intact. The coils were severely stretched at the distal tip and the safety ribbon was exposed. A device history record (dhr) review was performed on the stimucath with no relevant findings. The instructions for use (ifu) was reviewed as a part of this complaint investigation. The ifu states "do not alter the catheter or any other kit/set component during placement, use, or removal. " the ifu describes suggested techniques to minimize the likelihood of catheter damage during removal and cautions users about the use of alcohol and acetone since they can weaken the structure of the polyurethane material. Other remarks: the reported complaint of a catheter leak could not be confirmed based on the condition of the sample received. Only a catheter piece was received. The returned catheter piece was not received in a form that would allow for functional testing to confirm a leak. A dhr review was performed on the catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of a catheter leak could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[71852569]
The customer alleges that during removal of the catheter high force was required. The tip of the removed catheter was uncoiled. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[73369761]
The lot number was not provided by the customer, therefore, a lot number was chosen based on the sales history of the customer. A device history record (dhr) review was performed on lot number 23f14e0748 and there were no relevant findings. Complaint verification testing could not be performed as no sample was returned by the customer for investigation. A dhr review was performed based on a lot number from the sales history of the customer, and there was no evidence to suggest a manufacturing related cause. The potential cause of the catheter unraveling could not be determined based upon the information provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00065 |
| MDR Report Key | 4570381 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-03-03 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-02-01 |
| Date Mfgr Received | 2015-06-16 |
| Date Added to Maude | 2015-04-06 |
| 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 SET |
| Generic Name | NERVE BLOCK SET |
| Product Code | OGJ |
| Date Received | 2015-03-03 |
| Returned To Mfg | 2015-06-01 |
| Catalog Number | AB-20608-S |
| Lot Number | 23F14E0748 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-03 |