MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-22 for IV START KIT - TEGADERM SECUREMENT 2.5 * 72424 manufactured by Medical Action Industries, Inc..
[20718266]
Tegaderm dressing in iv kit has portion folded onto itself, which makes it difficult to use on the patient. A separate dressing from stock was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3631488 |
| MDR Report Key | 3631488 |
| Date Received | 2014-01-22 |
| Date of Report | 2014-01-22 |
| Date of Event | 2014-01-13 |
| Report Date | 2014-01-22 |
| Date Reported to FDA | 2014-01-22 |
| Date Reported to Mfgr | 2014-02-18 |
| Date Added to Maude | 2014-02-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV START KIT - TEGADERM SECUREMENT 2.5 |
| Generic Name | KIT, WOUND DRESSING |
| Product Code | MCY |
| Date Received | 2014-01-22 |
| Model Number | * |
| Catalog Number | 72424 |
| Lot Number | 177909 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 500 EXPRESSWAY DRIVE SOUTH BRENTWOOD NY 11717 US 11717 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-22 |