MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2008-04-11 for TRANSTAR PATIENT MOUNT MONITORING KIT MX9501T manufactured by Smiths Medical, Asd..
[811519]
Rep health region reported to smiths medical that the tubing was coming apart. The central venous pressure line broke at the transducer proximal to the stopcock. There was no patient injury or treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8026472]
Product has been received from the customer; however, smiths has not yet completed its investigation into this issue. A follow up report will be submitted as soon as the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616567-2008-00029 |
| MDR Report Key | 1028072 |
| Report Source | 01,06,07 |
| Date Received | 2008-04-11 |
| Date of Report | 2008-03-12 |
| Date Mfgr Received | 2008-03-12 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-10-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRI DAVIS |
| Manufacturer Street | 6250 SHIER-RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING, SA DE CB |
| Manufacturer Street | CARRETERA MIGUEL ALEMAN,KM21.7 |
| Manufacturer City | APODACA, MONTERREY 66600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 66600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSTAR PATIENT MOUNT MONITORING KIT |
| Generic Name | PRESSURE MONITORING SET |
| Product Code | DPT |
| Date Received | 2008-04-11 |
| Returned To Mfg | 2008-03-28 |
| Model Number | NA |
| Catalog Number | MX9501T |
| Lot Number | 1239925 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1027101 |
| Manufacturer | SMITHS MEDICAL, ASD. |
| Manufacturer Address | DUBLIN OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-11 |