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 2014-10-06 for ARROW CONTINUOUS NERVE BLOCK KIT AB-19608-KS manufactured by Arrow Intl., Inc..
[19374090]
A visual, functional and dimensional inspection could not be performed as no sample was returned by the customer for investigation. A device history record review was performed on the stimucath with no relevant findings. A corrective action is not required at this time as the potential root cause could not be determined based on the info provided and without a sample. Complaint verification testing could not be performed because no sample was returned for analysis. The device history records for the stimucath were reviewed with no evidence of suggest a mfg related cause. The potential cause of a catheter leak could not be determined based on the info provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
[19401369]
The event is reported as: the customer alleges that the catheter had a pin hole size leak located outside of the patient's body. The catheter was removed and there was no patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2014-00404 |
| MDR Report Key | 4152522 |
| Report Source | 05,06,07 |
| Date Received | 2014-10-06 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-09-12 |
| Date Mfgr Received | 2014-09-17 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-10-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| 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 KIT |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2014-10-06 |
| Catalog Number | AB-19608-KS |
| Lot Number | 23F14C0764 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-06 |