MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ANGIO DRAPE CARDIAC PACK

Catalog Number	DYNJ51615N
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, during a procedure after the towels got wet with "blood and fluids", there was "lint" from the towels noted on the physician's gloves and "the interventional wire as the physician was inserting a ivus catheter".The customer reported the physician "cleaned" their gloves and the "lint" was "cleaned off wire and catheter".The customer reported unused towels were then "placed over the current towels" but, "lint kept reappearing during the end of the case".The customer did not report any serious injury, medical intervention, or follow-up care needed related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, during a procedure after the towels got wet with "blood and fluids", there was "lint" from the towels noted on the physician's gloves and "the interventional wire as the physician was inserting a ivus catheter".

• Common Device Name: ANGIO DRAPE CARDIAC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19043354
• Report Number: 1423395-2024-00388
• Device Sequence Number: 12568403
• Product Code: OES
• UDI-Device Identifier: 40195327418947
• UDI-Public: 40195327418947
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 04/04/2024

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: DYNJ51615N
• Device Lot Number: 23IMH204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/04/2024
• 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