MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE HEPARIN

Model Number	INNOVANCE HEPARIN
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Customer stated one vial of innovance heparin reagent was found to be broken.There was no damage to the outer box and other vials.There have been no other complaints regarding broken vials of innovance heparin reagent.Damage to the vial during shipping, damage during the filling and packaging process, and damage due to customer handling and storage all cannot be ruled out as potential causes of 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
A lab technician cut their finger on a broken vial of innovance heparin reagent while opening the outer box of the innovance heparin reagent kit.The lab technician washed out the cut for 10 minutes with water.No medical intervention was required.There are no known reports of adverse health consequences due to this event.

• Brand Name: INNOVANCE HEPARIN
• Common Device Name: INNOVANCE HEPARIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 12143309
• Report Number: 9610806-2021-00052
• Device Sequence Number: 4198937
• Product Code: KFF
• UDI-Device Identifier: 00842768017438
• UDI-Public: 00842768017438
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162540
• 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): 07/09/2021

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: 01/25/2023
• Device Model Number: INNOVANCE HEPARIN
• Device Catalogue Number: 10873535
• Device Lot Number: 554049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1