MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-26 for WATER BATH TRAY 530.512 manufactured by Synthes (usa) Monument.
[21751106]
It was reported that a water bath tray was returned to the office after the hospital complained that the water level line in the tray was showing signs of rust. They noted that the rust seemed to be leaching into sterile water when the bath was filled.
Patient Sequence No: 1, Text Type: D, B5
[21883741]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated (b)(4) 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A review of synthes device history records for manufacturing revealed no complaint related issues. Manufacturing evaluation visual inspection revealed the returned unit showed general wear on all outside surfaces including scratches and dings. The unit showed discoloration/spotting and minor scratches on inside surfaces. The unit is significantly bent in one corner of the top flange, which would prevent the unit from functioning per specification. This bent corner is not a result of any manufacturing processes. The unit shows some discoloration on the laser etched water level lines.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2013-10006 |
| MDR Report Key | 2986458 |
| Report Source | 05,07 |
| Date Received | 2013-02-26 |
| Date of Report | 2011-02-24 |
| Date Mfgr Received | 2013-01-27 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2013-05-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | T. MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19880 |
| Manufacturer Country | US |
| Manufacturer Postal | 19880 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES (USA) MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE. |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER BATH TRAY |
| Product Code | JTQ |
| Date Received | 2013-02-26 |
| Returned To Mfg | 2011-06-02 |
| Catalog Number | 530.512 |
| Lot Number | 5101604 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) MONUMENT |
| Manufacturer Address | MONUMENT CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-26 |