MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-06-07 for TRANSTAR SINGLE LINE SET MX20984 manufactured by Smiths Medical.
[669997]
The reporter stated that the breakage or leaking from the product. No product was saved. The glue bonding the flushing mechanism to the blue plate transducer becomes loose while attaching a new flush line to the luer lock end below the flush. There was no pt injury or treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[7957198]
The customer indicated that there was no product available for return. Since there was no lot number available, the review of the device history record could not be performed. Review of the complaint database for the previous 24 months indicates this is the second reported issue of this type on this product code. The previous event was due to further processing and assembly of the transducer after leaving smiths, not a smiths manufacturing issue. This incident could also be related to the same issue however without product for evaluation this can not be confirmed. Smiths was unable to confirm this issue without benefit of returned product evaluation. An add'l report wille be submitted should info become available that impacts the outcome of smiths' investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616567-2007-00009 |
| MDR Report Key | 862943 |
| Report Source | 05,06 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-05-09 |
| Date Mfgr Received | 2007-05-09 |
| Date Added to Maude | 2008-02-11 |
| 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 | TERRIE DAVIS |
| Manufacturer Street | 6250 SHIER-RINGS RD. |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer G1 | MEDEX DE MEXICO, S.A. |
| Manufacturer Street | CARRETERA MIGUEL ALEMAN,KM21.7 |
| Manufacturer City | APODACA, MONTERREY |
| Manufacturer Country | MX |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSTAR SINGLE LINE SET |
| Generic Name | PRESSURE MONITORING SET |
| Product Code | DPT |
| Date Received | 2007-06-07 |
| Model Number | NA |
| Catalog Number | MX20984 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 958874 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-07 |