MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for URI-DRAIN EXTENSION TUBING WITH LATEX CONNECTOR - 8.5MM manufactured by Covidien Llc.
[51742085]
Caregiver was changing from the night time urinary collection bag to the daytime leg bag. The caregiver used a new hollister leg bag (9805) with extension tubing (kendall 8884731900 731900 uri-drain extension tubing with latex connector - 8. 5mm x 18"). Caregiver neglected to remove the cap from the extension tubing and inserted the end of the tubing with the cap still in place into the latex connection of the urinary catheter. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063901 |
| MDR Report Key | 5856049 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-08-04 |
| Date of Event | 2016-08-01 |
| Date Added to Maude | 2016-08-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHARMACIST |
| 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 | URI-DRAIN EXTENSION TUBING WITH LATEX CONNECTOR - 8.5MM |
| Generic Name | URI-DRAIN EXTENSION TUBING WITH LATEX CONNECTOR - 8.5MM |
| Product Code | NNW |
| Date Received | 2016-08-04 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-08-04 |