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

Model Number CONTROL PLASMA N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2018

Event Type  malfunction  

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 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
• Type of Device: CONTROL PLASMA N
• 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: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7436077
• MDR Text Key: 106259680
• Report Number: 9610806-2018-00044
• Device Sequence Number: 1
• Product Code: GGN
• UDI-Device Identifier: 00842768009174
• UDI-Public: 00842768009174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2018
• 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
• Patient Age: 50 YR