MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-06 for CARDIAC CATHETERIZATION PACK AV010892-15 manufactured by Medical Action Industries.
[42425958]
Ink from the label, white 4" x 2", p/n 5300825 is peeling away from the label and settling in the heparin/saline bowl. Labels are part of a cardiac catheterization pack mfg by (b)(4). No adverse patient event occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061589 |
| MDR Report Key | 5566930 |
| Date Received | 2016-04-06 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-04-05 |
| Date Added to Maude | 2016-04-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARDIAC CATHETERIZATION PACK |
| Generic Name | 4"X2" HEP/SALINE SYRINGE LABELS |
| Product Code | OES |
| Date Received | 2016-04-06 |
| Catalog Number | AV010892-15 |
| Lot Number | 1054565 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES |
| Manufacturer Address | TOANO VA 23168 US 23168 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-06 |