MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT

Model Number	DADE ACTIN FSL ACTIVATED PTT REAGENT
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was not wearing gloves at the time of the event.The customer reported that the reagent vial was found to be empty on arrival.The examination of the picture of the reagent vial provided by the customer indicates that the glass was broken structurally caused by a major impact.The label was applied correctly, and the glass pieces were attached to the label as well, indicating that the vial was intact during labeling.Siemens reviewed the manufacturing records for the reagent and no issues regarding glass breakage or screw caps were reported.Damage to the vial during shipping cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The device is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A customer scraped their finger while opening a vial of dade actin fsl activated ptt reagent.The customer disinfected and bandaged the wound.No medical intervention was required beyond first aid.There are no reports of adverse health consequences due to this event.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Common Device Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11195983
• Report Number: 9610806-2021-00017
• Device Sequence Number: 11835833
• Product Code: GGW
• UDI-Device Identifier: 00842768003875
• UDI-Public: 00842768003875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K863594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: 02/03/2022
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445713
• Device Lot Number: 562614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1