MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number DADE INNOVIN

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Laceration(s) (1946)

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Sysmex informed siemens that a customer sustained an injury to the hand while handling a dade innovin reagent vial.All additional reagent boxes and vials that were included in the delivery box were examined; they were in good condition.Siemens searched for similar complaints from the manufacturing date of the reagent to 20-feb-2023 and found that no other similar complaints were received for this reagent lot.The customers facility's handling of the material, as well as transport, storage and packaging of the reagent, potentially contributed to the event.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

Sysmex reported to siemens that a customer sustained an injury to the hand while opening a dade innovin vial, which was directly extracted from the packaging box.The customer demonstrated the neck of the vial was broken.The customer was then given a mini x-ray to ensure that there were no glass fragments in the wound.The wound was cleaned and disinfected and protected with steri-strips.No further treatment was necessary.The customer returned to work the same day.The customer was wearing a lab coat and latex gloves at the time of the incident.There are no known reports of adverse health consequences due to this event.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and have not been verified.

• Brand Name: DADE INNOVIN
• Type of Device: DADE INNOVIN
• 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: 16482208
• MDR Text Key: 310957721
• Report Number: 9610806-2023-00006
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2023

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
• Device Operator: Health Professional
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 564606A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female