MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-18 for BARD NOT AVAILABLE manufactured by C.r. Bard, Inc. Corporate Offices.
[32154893]
Pt's triple lumen catheter (blue lumen) began leaking from a pin point hole while being flushed with normal saline by the clinical staff member.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5246107 |
| MDR Report Key | 5246107 |
| Date Received | 2015-11-18 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-10-09 |
| Date Facility Aware | 2015-10-09 |
| Report Date | 2015-11-13 |
| Date Reported to FDA | 2015-11-13 |
| Date Reported to Mfgr | 2015-11-13 |
| Date Added to Maude | 2015-11-24 |
| 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 | 0 |
| Brand Name | BARD |
| Generic Name | CENTRAL LINE |
| Product Code | OFF |
| Date Received | 2015-11-18 |
| Model Number | NOT AVAILABLE |
| Catalog Number | NOT AVAILABLE |
| Lot Number | NOT AVAILABLE |
| Operator | NO INFORMATION |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. CORPORATE OFFICES |
| Manufacturer Address | 730 CENTRAL AVENUE MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-18 |