MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATH LAB PACK WEST

Catalog Number	DYNJ42023C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on 02/26/2024 the line was being flushed after power injection when the syringe "cracked" causing "blood to splash on the md's face and eyes".The customer reported the "md" washed out his eyes in the eyewash station and is required to have follow up labs due to exposure.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, or medical intervention associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that on 02/26/2024 the line was being flushed after power injection when the syringe "cracked" causing "blood to splash on the md's face and eyes".

• Common Device Name: CATH LAB PACK WEST
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18975597
• Report Number: 1423395-2024-00368
• Device Sequence Number: 6213334
• Product Code: OEZ
• UDI-Device Identifier: 40889942888444
• UDI-Public: 40889942888444
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ42023C
• Device Lot Number: 24BBH333
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown