MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-15 for CAREFUSION PCA TUBING manufactured by Carefusion 211, Inc.. Dba Carefusion.
[67565857]
Patient Sequence No: 1, Text Type: N, H10
[67565858]
Patients iv tubing found to be leaking. Assessed tubing and determined that it was the pca tubing leaking. Crack found in hard plastic connector end of tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6331500 |
| MDR Report Key | 6331500 |
| Date Received | 2017-02-15 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-11-03 |
| Report Date | 2016-11-10 |
| Date Reported to FDA | 2016-11-10 |
| Date Reported to Mfgr | 2016-11-10 |
| Date Added to Maude | 2017-02-15 |
| 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 | CAREFUSION PCA TUBING |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2017-02-15 |
| Lot Number | 11611800 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 211, INC.. DBA CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PKWY. YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-15 |