MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-12 for ARROW CONTINUOUS NERVE BLOCK KIT AB-19608-KS manufactured by Arrow Intl., Inc..
[4573954]
The event is reported as: the customer alleges that the catheter started to unravel and shear as it began to be used. The customer was discontinued and a new catheter was used successfully. No report of a patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[11917030]
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00078 |
| MDR Report Key | 3938099 |
| Report Source | 05,06 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-02-14 |
| Date of Event | 2014-02-01 |
| Date Mfgr Received | 2014-02-14 |
| Date Added to Maude | 2014-07-29 |
| 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. |
| 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 | 2014-03-12 |
| Returned To Mfg | 2014-02-27 |
| Catalog Number | AB-19608-KS |
| Lot Number | 23F13J104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-03-12 |