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

Catalog Number	DYNJ23538D
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the facility small bugs were found in one of the syringes.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact 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
Per the facility small bugs were found in one of the syringes.

• Common Device Name: CATH LAB PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18933538
• Report Number: 1423395-2024-00127
• Device Sequence Number: 15775749
• Product Code: OES
• UDI-Device Identifier: 10193489358278
• UDI-Public: 10193489358278
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 03/19/2024

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 Catalogue Number: DYNJ23538D
• Device Lot Number: 22AME246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown