MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for IV START KIT DYNDV1888 manufactured by Medline Industries, Inc..
[82596091]
Patient Sequence No: 1, Text Type: N, H10
[82596092]
Nurse opened iv kit, placed tourniquet from kit and removed chloroprep pad to scrub the skin. When the nurse started to scrub the skin she found shards of glass (similar to ampule top) under scrub pad. Skin intact with no bleeding noted but patient indicated she felt small pieces of glass on her skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6791424 |
| MDR Report Key | 6791424 |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-08-04 |
| Report Date | 2017-08-07 |
| Date Reported to FDA | 2017-08-07 |
| Date Reported to Mfgr | 2017-08-07 |
| Date Added to Maude | 2017-08-14 |
| 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 | 2017-08-14 |
| Catalog Number | DYNDV1888 |
| Lot Number | 17DB8564 |
| ID Number | GTIN(01)10888277877535 |
| Device Expiration Date | 2019-12-31 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |