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

Model Number CONTROL PLASMA P

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

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 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
• Type of Device: CONTROL PLASMA P
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 11574856
• MDR Text Key: 257209854
• Report Number: 9610806-2021-00034
• Device Sequence Number: 1
• Product Code: GGC
• UDI-Device Identifier: 00842768011580
• UDI-Public: 00842768011580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1