MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-17 for CONTROL PLASMA N 10446235 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[106259680]
The customer contacted siemens customer care center and reported that they sustained an injury to the hand. The customer reported that there was no damage to the outer packaging of the control plasma n vial, the vial appeared to be intact, and the vial was previously unpacked. There were no reports of other control plasma n vials affected by this event. Siemens investigated the event and determined that the customer's handling, transport, storage or packaging of the control vial potentially contributed to the breakage of the vial. The cause of the event is unknown. The reagent is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[106259681]
A customer reported that a vial of control plasma n broke in their hand, causing an injury to their hand. The customer went to the emergency room (er) and a band aid was applied to the injury. Based on the hospital's exposure protocol, the customer was also tested for infectious diseases, including (b)(6) and the customer was scheduled for follow up testing. The customer stated that they were wearing personal protective equipment, including gloves, at the time of the event. There are no known reports of patient intervention or adverse health consequences due to the breakage of the control plasma n vial.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00044 |
| MDR Report Key | 7436077 |
| Date Received | 2018-04-17 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-03-23 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2018-04-17 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING- STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONTROL PLASMA N |
| Generic Name | CONTROL PLASMA N |
| Product Code | GGN |
| Date Received | 2018-04-17 |
| Model Number | CONTROL PLASMA N |
| Catalog Number | 10446235 |
| Lot Number | 507736 |
| Device Expiration Date | 2019-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-17 |