MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-08 for WATER BATH STERILITY COVER 530.514 manufactured by Synthes Usa.
[48045461]
No reported patient or surgical involvement. Event date: the exact date of breakage is unknown; however, the issue was discovered upon delivery on (b)(6) 2016. Device product code? Xxx? Is being used to report unavailable code jtq, which corresponds with the reported common name. Partial udi number: (b)(4) lot unknown. Implant and explant dates: device is an instrument and is not implanted or explanted. The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter hospital contact number: (b)(6). Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[48045462]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the sterile tip of the device was broken during transport from the warehouse to the hospital. No patient or procedural involvement noted. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[48528125]
Product investigation summary: the evaluation has shown that the acrylic glass sterility cover for the water bath is cracked, without fragmentation, at its weakest point. The overall condition of the cover is very used with scratches all over and a dull surface. Based on this information, it can be concluded that this was an often and intensely used loan set device. Also, this cover was phased out in march, 2011. A review of shipment transactions has shown that this part was last shipped to (b)(4) in may, 2008. Based on this information, it can be assumed that this device is at least eight (8) years old. Based on these findings, a manufacturing related issue can be excluded. Based on the complaint description, it can be assumed that inappropriate handling during transportation led to the damage on the cover. No product related issues were detected. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2016-13071 |
| MDR Report Key | 5707162 |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-25 |
| Date Mfgr Received | 2016-06-14 |
| Date Added to Maude | 2016-06-08 |
| 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 | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES USA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER BATH STERILITY COVER |
| Generic Name | BATH, INCUBATORS, WATER/ALL |
| Product Code | JTQ |
| Date Received | 2016-06-08 |
| Returned To Mfg | 2016-06-14 |
| Catalog Number | 530.514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-08 |