MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-09-24 for ARROW FLEXBLOCK KIT: ECHO CATH, 17GX8CM STM NDL FB-19608-K manufactured by Arrow International, Inc..
[18708950]
The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[18734758]
The event is reported as: the customer alleges that the lidocaine vial shattered upon breaking at the scoreline. No patient/user injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2014-00383 |
| MDR Report Key | 4142694 |
| Report Source | 06,07 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-09-03 |
| Date of Event | 2014-09-01 |
| Date Mfgr Received | 2014-09-03 |
| Date Added to Maude | 2014-10-10 |
| 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 | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW FLEXBLOCK KIT: ECHO CATH, 17GX8CM STM NDL |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2014-09-24 |
| Catalog Number | FB-19608-K |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-24 |