MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for MEDICAL ACTION INDUSTRIES 267004 manufactured by Medical Action Industries, Inc..
[140296088]
Noticed by our central sterile processing department staff that the medical action iv start kits have the lot number listed as the expiration date as well as the lot#. Manufacturer response for kit, (brand not provided) (per site reporter). Sent email to (b)(6) and explained the mistake.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8463555 |
| MDR Report Key | 8463555 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-26 |
| Report Date | 2019-03-27 |
| Date Reported to FDA | 2019-03-27 |
| Date Reported to Mfgr | 2019-03-29 |
| Date Added to Maude | 2019-03-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | I.V. START KIT |
| Product Code | LRS |
| Date Received | 2019-03-29 |
| Model Number | 267004 |
| Catalog Number | 267004 |
| Lot Number | 254108 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 25 HEYWOOD RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |