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..
[178958730]
Infant with arterial blood transducer in place, but it was not reading a waveform well and had trouble drawing from it. Found to clot off during the night and the line was removed. The lot numbers that were found to not work well were 1190543 and 1190269, but on this night the newest lot that was shipped was tried - 1191159. The nurses found that the older lot numbers: 1182159, 1181934 and 1183165 had all worked well. But the number of these products were running low, so the new lot was tried. The nurses reported that it was "bouncing" in and out of good wave form. After the tubing had been changed, 5 hours later the line had clotted and had to be pulled. There was no known injury to any patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9699911 |
| MDR Report Key | 9699911 |
| Date Received | 2020-02-12 |
| Date of Report | 2019-10-31 |
| 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 |
| Operator | HEALTH PROFESSIONAL |
| 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 |