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..
[5847004]
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
[13374907]
(b)(4). Complaint verification testing could not be performed as the actual complaint sample was not received. The customer returned a sealed kit only. Upon opening the sealed kit, it could be seen that all medical ampules were intact. A device history record review was performed on the kit and the medication ampules with no evidence to suggest a manufacturing related cause. The potential cause of broken medication ampules could not be determined based upon the information provided and without the actual complaint sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00242 |
| MDR Report Key | 4856825 |
| 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 |