MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for BARD RELIAVAC TUBING manufactured by Bard.
[91229531]
This case involves a (b)(6) female who presented for a right total knee arthroplasty due to primary osteoarthritis of the right knee on (b)(6). The pt tolerated the procedure well. During removal of the hemovac drain on (b)(6), the nurse had difficulty removing the drain tubing. She repositioned the knee and the drain came right out after a gentle pull. The end of the tube was jagged, flat and bent. The orthopedic surgeon was notified and decided to take the pt to the operating room to evaluate for the drain tip. During surgery, he found a piece of hemovac drain near the femoral notch. It was free floating and not stuck on anything. The surgery was completed and the pt continues to recover as an inpatient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073139 |
| MDR Report Key | 7002869 |
| Date Received | 2017-11-06 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-11-01 |
| Date Added to Maude | 2017-11-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 RELIAVAC TUBING |
| Generic Name | CONNECTOR, CATHETER |
| Product Code | GCD |
| Date Received | 2017-11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD |
| Manufacturer Address | COVINGTON VA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-11-06 |