MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-29 for ARROW SPINAL ANES/EPIDURAL CATH KIT AK-05560 manufactured by Arrow International Inc..
[4950057]
The event is reported as: the customer alleges that the epidural tray contained a broken ampule. No patient/user injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[12424771]
A visual, functional and dimensional inspection could not be performed as no sample was returned by the customer for investigation. No lot number was provided by the customer. A device history record review was performed on lot number 23f14g0431 from sales history. A device history record review was performed on the kit and the medication ampules with no relevant findings. A corrective action is not required at this time as a potential root cause could not be determined based on the information provided and without a sample. Complaint verification testing could not be performed because no sample was returned for analysis. The potential cause of broken medication ampules could not be determined based upon the information provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00388 |
| MDR Report Key | 4138030 |
| Report Source | 05,06 |
| Date Received | 2014-09-29 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-09-03 |
| Date Mfgr Received | 2014-09-15 |
| Date Added to Maude | 2014-10-08 |
| 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 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 SPINAL ANES/EPIDURAL CATH KIT |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2014-09-29 |
| Catalog Number | AK-05560 |
| 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 INTERNATIONAL INC. |
| Manufacturer Address | READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-29 |