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 2015-09-17 for ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT ASK-20608-ROP manufactured by Arrow International Inc..
[26071299]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[26071300]
The customer alleges that when the doctor was injecting the drug into the catheter, he noticed that the catheter had cracks all the way down. The catheter leaked along the catheter. No patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
[31239625]
(b)(4). The customer returned one 20ga stimucath for investigation. A visual exam was performed and it was observed that the catheter was used as biological material could be seen on both the distal and proximal exposed coils. The coils at the proximal end were damaged. The safety ribbon was present and attached, however, the most distal tip of the coils were unraveled. No other defects were observed. Functional testing was also performed and no leaks were detected. The lot number provided by the customer is not a valid lot number for the reported product code. A device history record review was conducted based on a lot number (23f15g1135) from sales history of the customer, and there were no relevant findings. The reported complaint of a catheter leak was not confirmed based on the sample received. The returned catheter passed a functional leak test and no cracks were detected on the catheter body. A dhr review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause. There were no functional issues found with the returned sample.
Patient Sequence No: 1, Text Type: N, H10
[31239626]
The customer alleges that when the doctor was injecting the drug into the catheter, he noticed that the catheter had cracks all the way down. The catheter leaked along the catheter. No patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00414 |
| MDR Report Key | 5084720 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-09-03 |
| Date Mfgr Received | 2015-10-20 |
| Date Added to Maude | 2015-09-17 |
| 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 | 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 PERIPHERAL NERVE BLOCK KIT |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2015-09-17 |
| Returned To Mfg | 2015-09-24 |
| Catalog Number | ASK-20608-ROP |
| Lot Number | 23F15E0139 |
| 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 | 2015-09-17 |