MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for LSL STERILE CENTRAL LINE KIT W/ BIOPATCH manufactured by Lsl Industries, Inc..
[105397864]
Patient Sequence No: 1, Text Type: N, H10
[105397865]
When training staff with the lsl sterile central line dressing kits, it was noted that gloves tear very easily and are difficult for staff to maintain sterility. Gloves are being discarded and better quality gloves are being used by staff. Request has been submitted for a higher quality of gloves to be in the kits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7428476 |
| MDR Report Key | 7428476 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-21 |
| Report Date | 2018-03-21 |
| Date Reported to FDA | 2018-03-21 |
| Date Reported to Mfgr | 2018-03-21 |
| Date Added to Maude | 2018-04-13 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LSL STERILE CENTRAL LINE KIT W/ BIOPATCH |
| Generic Name | DRESSING CHANGE TRAY |
| Product Code | OXQ |
| Date Received | 2018-04-13 |
| Lot Number | 10 7L3111 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSL INDUSTRIES, INC. |
| Manufacturer Address | 5535 N. WOLCOTT AVE. CHICAGO IL 60640 US 60640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |