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

Model Number	CONTROL PLASMA P
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The customer was wearing personal protective equipment (ppe) at the time of the event.No other issues with any other control plasma p bottles were reported at this site.The customer indicated that a shipping or handling issue may have occurred and the box may have been dropped.Glass pieces were also reported to be found in the box.Siemens reviewed the manufacturing order documents for control plasma p.There was no indication for a systematic failure of processes or any material issues.Customer handling, transport, storage or packaging cannot be ruled out as contributing factors to the event.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
The customer cut their thumb due to a control plasma p bottle that broke during reconstitution.The glass of the bottle cut their thumb as they were opening the bottle.The cut required antiseptic and a bandage.The customer has followed the site's exposure protocols.There are no known reports of adverse health consequences due to this event.

• Brand Name: CONTROL PLASMA P
• Common Device Name: CONTROL PLASMA P
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11574856
• Report Number: 9610806-2021-00034
• Device Sequence Number: 2988256
• Product Code: GGC
• UDI-Device Identifier: 00842768011580
• UDI-Public: 00842768011580
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 07/07/2021
• Device Model Number: CONTROL PLASMA P
• Device Catalogue Number: 10446472
• Device Lot Number: 556719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1