MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for IV START KIT DYND74283 manufactured by Medline Industries Inc..
[31351055]
Patient Sequence No: 1, Text Type: N, H10
[31351056]
Iv start kits have a tegaderm dressing that staff are having trouble removing from packaging. The tegaderm is wrinkled and unusable. No patient harm but necessitating gathering other sets to get necessary dressing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5229219 |
| MDR Report Key | 5229219 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-10-27 |
| Report Date | 2015-10-29 |
| Date Reported to FDA | 2015-10-29 |
| Date Reported to Mfgr | 2015-10-29 |
| Date Added to Maude | 2015-11-17 |
| 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 |
| 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 | IV START KIT |
| Generic Name | KIT, I.V. START |
| Product Code | LRS |
| Date Received | 2015-11-17 |
| Catalog Number | DYND74283 |
| Lot Number | 15SB5302 |
| Device Expiration Date | 2018-03-01 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-17 |