MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-19 for TRANSTAR PRESSURE MONITORING SYSTEM MX9505T manufactured by Smiths Medical, Inc..
[5114344]
A report was received stating during set-up, tubing separation occurred at the male luer lock. As this issue was found during set-up, there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[12686648]
The device was not returned to the manufacturer for device evaluation. When and if the device becomes available and is returned for evaluation, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2014-01003 |
| MDR Report Key | 4379713 |
| Report Source | 06 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-12-18 |
| Report Date | 2014-12-18 |
| Date Reported to FDA | 2014-12-18 |
| Date Mfgr Received | 2014-11-25 |
| Device Manufacturer Date | 2013-06-13 |
| Date Added to Maude | 2015-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX ROAD |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | SMITHS MEDICAL |
| Manufacturer Street | 6250 SHIER-RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSTAR PRESSURE MONITORING SYSTEM |
| Generic Name | DPT - PROBE, BLOOD-FLOW, EXTRAVASCULAR |
| Product Code | DPT |
| Date Received | 2014-12-19 |
| Model Number | NA |
| Catalog Number | MX9505T |
| Lot Number | 2473887 |
| ID Number | NA |
| Device Expiration Date | 2016-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL, INC. |
| Manufacturer Address | DUBLIN OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-19 |