MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for NIPRO SAFE TOUCH II FS-152530BC manufactured by Nipro.
[77418937]
Ccht noted that there were a lot of air in the line. Stopped treatment to recirculate lines to remove the air bubbles. Resumed treatment after removing the air but noticed that there was a lot of blood leaking around the arterial needle site when she restarted treatment and was unable to control the bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6633865 |
| MDR Report Key | 6633865 |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-05-23 |
| Date Facility Aware | 2017-05-23 |
| Report Date | 2017-05-30 |
| Date Reported to Mfgr | 2017-05-30 |
| Date Added to Maude | 2017-06-12 |
| 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 |
| 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 | NIPRO SAFE TOUCH II |
| Generic Name | NIPRO FISTULA NEEDLE 15G |
| Product Code | FIE |
| Date Received | 2017-05-31 |
| Model Number | FS-152530BC |
| Lot Number | 16C16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO |
| Manufacturer Address | BRIDGEWATER NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-05-31 |