MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TOWEL,OR,DSP,ST,BLUE,STD,4/PK

Model Number	MDT2168284
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "the operating room (or) towels having lint/fibers & it spread all over to the surgical gloves, instruments, drapes & potentially on the patient.This is happening in the middle of the case." email received by bsn, rn, cnor, uc (b)(6) medical center, with additional information related to this incident.Reporter states on (b)(6) 2021 "during an ascending aortic replacement and aortic valve replacement procedure, the lint from the towels made contact with the open site through the surgeon and staff gloves." reporter states, "the lint were removed by picking it with forceps.In addition, staff removed the towels and gloves.The surgeon had to pause/stopped the surgery and removed the lint and do further inspection of the severity of the situation.As a result, the patient did require additional general anesthesia." no serious injury has been reported at this time.Samples are not available for return and evaluation therefore, a root cause will be difficult if not impossible to determine.Due to the reported incident, medical intervention and 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
It was reported, "the operating room (or) towels having lint/fibers & it spread all over to the surgical gloves, instruments, drapes & potentially on the patient.This is happening in the middle of the case.".

• Brand Name: MEDLINE
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,STD,4/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11681357
• Report Number: 1417592-2021-00073
• Device Sequence Number: 3091837
• Product Code: FRL
• UDI-Device Identifier: 10080196282739
• UDI-Public: 10080196282739
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: MDT2168284
• Device Catalogue Number: MDT2168284Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 125