MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-21 for TRANSTAR 84 IN SINGLE MONITORING KIT MX9505T manufactured by Smiths Medical Asd, Inc..
[1755955]
The reporter stated that the device leaked from the stopcock during use. There was no reported patient injury or treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8853317]
(b)(4). Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2010-00465 |
| MDR Report Key | 1882481 |
| Report Source | 06 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-10-19 |
| Date of Event | 2010-09-21 |
| Date Facility Aware | 2010-09-21 |
| Report Date | 2010-10-19 |
| Date Reported to FDA | 2010-10-19 |
| Date Mfgr Received | 2010-09-21 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2010-12-27 |
| 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 ASD |
| 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 84 IN SINGLE MONITORING KIT |
| Generic Name | PRESSURE MONITORING SET |
| Product Code | DPT |
| Date Received | 2010-10-21 |
| Model Number | NA |
| Catalog Number | MX9505T |
| Lot Number | 1549351 |
| ID Number | NA |
| Device Expiration Date | 2012-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | DUBLIN OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-21 |