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 2014-03-07 for ARROW CONTINUOUS NERVE BLOCK KIT AB-05060-PK manufactured by Arrow Intl., Inc..
[4493049]
Complaint alleges that the clinician was unable to view the tip of the catheter during the removal of the product.
Patient Sequence No: 1, Text Type: D, B5
[12078204]
The customer returned one 19 ga stimucath for evaluation. A visual exam was performed and adhesive residue could be seen on the catheter body exterior. There was no visible exposed coil at the distal tip. The exposed coil at the proximal end appeared to be damaged and the coils at the most proximal end appeared to be separated. The proximal weld was intact and the safety ribbon was present. Microscopic examination into the distal end did not reveal the presence of the distal tip. With the extrusion removed, it could be seen that the distal tip was intact and the distal ball weld was present. A wire was inserted into the distal end of the catheter and it was found that the distal metal tip was retracted approximately 8mm, which is within specifications. The reported complaint of the tip of the catheter not visible during removal was confirmed based on the condition of the sample received. The returned catheter was received with the distal tip retracted approximately 2mm into the extrusion. The exposed coil at the distal end was found to be out of specification. Based on the information provided and the results of the investigation, the potential root cause of this complaint is manufacturing related. This catheter's appearance with the movement of the extrusion over the guide wire is similar to the appearance of samples being investigated under capa (b)(4) for out of specification exposed wire length of anesthesia catheters. Therefore, capa (b)(4) will also investigate this complaint issue since the two appear to be related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00053 |
| MDR Report Key | 3916711 |
| Report Source | 05,06,07 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-02-10 |
| Date of Event | 2014-01-05 |
| Date Mfgr Received | 2014-01-21 |
| Date Added to Maude | 2014-07-17 |
| 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 | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| 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 |
| Remedial Action | OT |
| 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 | 2014-03-07 |
| Returned To Mfg | 2014-01-21 |
| Catalog Number | AB-05060-PK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-03-07 |