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 2015-06-19 for ARROW SPINAL ANES/EPIDURAL CATH KIT AK-05560 manufactured by Arrow International Inc..
[22060610]
The customer alleges that the medical ampules were found broken in the tray. No patient or user injury reported.
Patient Sequence No: 1, Text Type: D, B5
[22281681]
(b)(4). The reported complaint of broken medication ampules in the tray could not be confirmed based on the sample received. The customer returned one opened kit for investigation. However, all of the medication ampules were received intact. A device history record review was performed on the kit and the medication ampules with no evidence to suggest a manufacturing related cause. There were no visual defects found with the returned sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00244 |
| MDR Report Key | 4856890 |
| Report Source | 05,06,07 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-05-18 |
| Date Mfgr Received | 2015-06-02 |
| Device Manufacturer Date | 2015-01-14 |
| Date Added to Maude | 2015-06-19 |
| 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 | 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 SPINAL ANES/EPIDURAL CATH KIT |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2015-06-19 |
| Returned To Mfg | 2015-06-08 |
| Catalog Number | AK-05560 |
| Lot Number | 23F15A0754 |
| Device Expiration Date | 2016-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-06-19 |