MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for BT-BALLOON TAMPONADE CATHETER FOR POSTPARTUM UTERINE HEMORRHAGE WITH EASY FILL I BTC-ESY manufactured by Utah Medical Products, Inc..
[175650739]
This report pertains to a utah balloon which was used on a pt. Bt - balloon tamponade catheter for postpartum uterine hemorrhage with easy fill inflation systems utah medical products (b)(4), btc-esy, lot# 1191599, exp 2024-09-17. During training, i opened the package and tried to connect the clear luer lock port to the blue stop cock and no matter what i did it would not screw on. First when i opened it on the clear luer lock part, the circular tube in it was bent to the side so i had to bend it back and it still wouldn't work. The lot number 1191599 on this device is the same lot number, reported in rm# 19-61223. The luer lock is visibly defective, however, it is difficult to photograph. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092249 |
| MDR Report Key | 9592607 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-07 |
| Date Added to Maude | 2020-01-15 |
| 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | BT-BALLOON TAMPONADE CATHETER FOR POSTPARTUM UTERINE HEMORRHAGE WITH EASY FILL I |
| Generic Name | INTRAUTERINE TAMPONADE BALLOON |
| Product Code | OQY |
| Date Received | 2020-01-14 |
| Model Number | BTC-ESY |
| Lot Number | 1191599 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | MIDVALE UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |