MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH CONTROL PLASMA N

Model Number	CONTROL PLASMA N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: CONTROL PLASMA N
• Common Device Name: CONTROL PLASMA N
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7436077
• Report Number: 9610806-2018-00044
• Device Sequence Number: 1637485
• Product Code: GGN
• UDI-Device Identifier: 00842768009174
• UDI-Public: 00842768009174
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K042333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2019
• Device Model Number: CONTROL PLASMA N
• Device Catalogue Number: 10446235
• Device Lot Number: 507736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR