MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-19 for CVL LINE * manufactured by *.
[5782706]
The clinician went into asses her patient and was planning to weigh the baby and the central venous (cvl) line snapped. She notified the charge nurse and then had another nurse who is a trained on repair of cvl breaks to come and repair it. When restarting fluids the clinician was unable to flush, and when continued to flush, the cvl started to leak at the site of repair. The advanced registered nurse practitioner (arnp) was aware and ordered new intravenous fluids (ivf) for a peripheral line. The arnp with surgeons was notified of issue and she advised to repair again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4765081 |
| MDR Report Key | 4765081 |
| Date Received | 2015-03-19 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-02-02 |
| Report Date | 2015-03-19 |
| Date Reported to FDA | 2015-03-19 |
| Date Reported to Mfgr | 2015-05-12 |
| Date Added to Maude | 2015-05-12 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVL LINE |
| Generic Name | KIT, WOUND DRESSING |
| Product Code | MCY |
| Date Received | 2015-03-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-19 |