MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for ADVIA 120/2120/2120I SHEATH/RINSE 10 L 10316869 manufactured by Siemens Healthcare Diagnostics Inc..
[129068880]
The customer contacted a siemens customer care center and reported that an operator sustained an injury when the handle of a 10 l advia sheath/rinse cubitainer detached from the cubitainer. Siemens advised the customer to use a "sack trolley" to transport the advia sheath/rinse cubitainer. Siemens investigated the event and the event appears to be isolated. The cause of the handle detaching from the advia sheath/rinse cubitainer is unknown. The catalog number, lot number, and unique identifier (udi) number were not available at the time of filing. The device is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[129068881]
The customer reported that an operator was injured while transporting a 10 l advia sheath/rinse cubitainer from their storage room to their laboratory as the handle on the cubitainer detached from the cubitainer. The operator injured her shoulder and hip and was referred to physiotherapy. There are no known reports of adverse health consequences due to the operator's injury from the handle detaching from the 10 l advia sheath/rinse cubitainer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00439 |
| MDR Report Key | 8112758 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2018-11-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | THERMO FISHER SCIENTIFIC |
| Manufacturer Street | 8365 VALLEY PIKE REGISTRATION # 1181121 |
| Manufacturer City | MIDDLETOWN VA 22645 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22645 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA 120/2120/2120I SHEATH/RINSE 10 L |
| Generic Name | ADVIA 120/2120/2120I SHEATH/RINSE 10 L |
| Product Code | GKL |
| Date Received | 2018-11-28 |
| Model Number | ADVIA 120/2120/2120I SHEATH/RINSE 10 L |
| Catalog Number | 10316869 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |