MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH OWREN'S VERONAL BUFFER

Model Number	OWREN'S VERONAL BUFFER
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The glass of the bottle 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 not damaged during labeling.There is no indication of a systematic failure of processes or any material issues.The most likely cause of the event was a shipping and handling issue.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
While opening a bottle of owren's veronal buffer (ovb), the customer received a cut on their finger after the bottle shattered in their hand.The customer cleaned the wound and did not seek medical attention.The box from which the broken bottle was taken had wet marks on it and looked physically damaged.The customer discarded the remaining bottles of ovb in the box.There are no known reports of adverse health consequences due to this event.

• Brand Name: OWREN'S VERONAL BUFFER
• Common Device Name: OWREN'S VERONAL BUFFER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 12468897
• Report Number: 9610806-2021-00062
• Device Sequence Number: 17429737
• Product Code: KQJ
• UDI-Device Identifier: 00842768003981
• UDI-Public: 00842768003981
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K050928
• 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): 09/14/2021

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: 02/16/2022
• Device Model Number: OWREN'S VERONAL BUFFER
• Device Catalogue Number: 10445724
• Device Lot Number: 554689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1