MAUDE Adverse Event Report: CARDINAL HEALTH CONTAINER SHARPS 5QT RED; CONTAINER, SHARPS

Model Number	8507SA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	08/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that on (b)(6) 2022, a nurse in the ed had an exposure related to the new sharps containers.When the nurse went to put a sharp in the container, there was an old sharp that was hanging there and when it fell into the box, it splashed blood on her face, arm, chest and neck.
Additional Manufacturer Narrative
A lot number was not available for review; however, a lot will not be released without meeting all criteria.No samples or pictures have been provided.Without samples or pictures, we are unable to observe the reported condition.If samples or pictures are received, the complaint may be re-opened and the investigation continued.An exact root cause could not be determined as there was not enough information or evidence available.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information is received warranting further analysis, the investigation will be resumed this complaint will be used for tracking purposes.

• Brand Name: CONTAINER SHARPS 5QT RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15372836
• Report Number: 1424643-2022-00623
• Device Sequence Number: 1725978
• Product Code: MMK
• UDI-Device Identifier: 10884521023284
• UDI-Public: 10884521023284
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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 Model Number: 8507SA
• Device Catalogue Number: 8507SA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown