MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-03-27 for ARROW CONTINUOUS NERVE BLOCK SETG AB-19608-S manufactured by Arrow Intl., Inc..
[5758631]
The customer alleges that on insertion the doctor experienced difficulty to advance the stimucath through the insulated plexus block needle. The stimucath got stuck in the needle. When the doctor pulled the stimucath back, the tip of the needle cut the stimucath catheter. The stimucath catheter and insulated plexus block needle were removed completely. Another attempt was successfully completed. No patient injury or complication reported.
Patient Sequence No: 1, Text Type: D, B5
[13177160]
Qn# (b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00092 |
| MDR Report Key | 4651088 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-09 |
| Date of Event | 2015-02-12 |
| Date Mfgr Received | 2015-03-09 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-05-13 |
| 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 BURTON, RN REGULATORY AFF |
| Manufacturer Street | 3015 CARRINGTON MILL BLVCD. |
| Manufacturer City | MORRISSVILLE 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 SETG |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2015-03-27 |
| Catalog Number | AB-19608-S |
| Lot Number | 23F13L0074 |
| Device Expiration Date | 2015-11-30 |
| 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 | 2015-03-27 |