MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for DELTRAN PLUS ABC-350NP manufactured by Utah Medical Products, Inc..
[178958777]
Infant with arterial blood transducer in place, but it was not reading a waveform well and had trouble drawing from it. It was found to be clotted off during the night and the line was removed. There was no known harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9699914 |
| MDR Report Key | 9699914 |
| Date Received | 2020-02-12 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-10-28 |
| Report Date | 2019-12-31 |
| Date Reported to FDA | 2019-12-31 |
| Date Reported to Mfgr | 2020-02-12 |
| Date Added to Maude | 2020-02-12 |
| 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 | 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 | DELTRAN PLUS |
| Generic Name | ARTERIAL BLOOD SAMPLING KIT |
| Product Code | CBT |
| Date Received | 2020-02-12 |
| Catalog Number | ABC-350NP |
| Lot Number | 1191159 |
| Device Availability | * |
| 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 | 2020-02-12 |