MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-03-30 for TRANSTAR KIDS KIT NEONATAL MONITORING KIT MX9533T manufactured by Smiths Medical.
[2893767]
The reporter stated that the plastic around the sample port was broken and leaking. There was no patient injury or treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[10179151]
The product has been received from the customer; however, smiths has not yet completed its investigation into this issue. An additional report will be submitted as soon as the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616567-2007-00001 |
| MDR Report Key | 2750699 |
| Report Source | 99 |
| Date Received | 2007-03-30 |
| Date of Report | 2007-02-28 |
| Date Mfgr Received | 2007-02-28 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2012-09-21 |
| 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 RD. |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | MEDEX DE MEXICO, S.A. |
| 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 KIDS KIT NEONATAL MONITORING KIT |
| Generic Name | PRESSURE MONITORING SET |
| Product Code | DPT |
| Date Received | 2007-03-30 |
| Returned To Mfg | 2007-03-26 |
| Model Number | NA |
| Catalog Number | MX9533T |
| Lot Number | 35G28MR01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-30 |