MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for UMBILI-CATH SINGLE-LUMEN SILICONE 4173505 manufactured by Utah Medical Products, Inc..
[144703583]
It was used as an umbilical arterial catheter and was sutured at 14 cm. The line was clamped to change iv fluids and it snapped just after the hub. There was no patient harm as the catheter was clamped. It was placed, and this occurred 3 days later. Clamped uac using 2x2 folded over line and hemostats clamped. After scrubbing the line, attempting to twist off the old iv tubing to replace with new when it just popped apart at the end of the catheter where it is attached to the hub.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8599363 |
| MDR Report Key | 8599363 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-05 |
| Report Date | 2019-04-10 |
| Date Reported to FDA | 2019-04-10 |
| Date Reported to Mfgr | 2019-05-10 |
| Date Added to Maude | 2019-05-10 |
| 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 |
| 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 | 3 |
| Brand Name | UMBILI-CATH |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2019-05-10 |
| Model Number | SINGLE-LUMEN SILICONE |
| Catalog Number | 4173505 |
| Lot Number | 1181222 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |