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

Model Number OWREN'S VERONAL BUFFER

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/18/2021

Event Type  malfunction  

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 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
• Type of Device: OWREN'S VERONAL BUFFER
• 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: 12468897
• MDR Text Key: 274597605
• Report Number: 9610806-2021-00062
• Device Sequence Number: 1
• Product Code: KQJ
• UDI-Device Identifier: 00842768003981
• UDI-Public: 00842768003981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050928
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• 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