MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for SURESTEP A319418AM manufactured by C.r. Bard, Inc..
[67112177]
Patient Sequence No: 1, Text Type: N, H10
[67112178]
Monitor could not sense temperature via probe in foley. Error message displayed on monitor screen stating no temperature probe found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6321772 |
| MDR Report Key | 6321772 |
| Date Received | 2017-02-10 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-10 |
| Report Date | 2016-12-21 |
| Date Reported to FDA | 2016-12-21 |
| Date Reported to Mfgr | 2016-12-21 |
| Date Added to Maude | 2017-02-10 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESTEP |
| Generic Name | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES |
| Product Code | EYB |
| Date Received | 2017-02-10 |
| Model Number | A319418AM |
| Catalog Number | A319418AM |
| Lot Number | NGAV3572 |
| Device Expiration Date | 2018-10-31 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-10 |