MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; TOWEL,OR,DSP,ST,BLUE,DLX,4/PK,20PK/CS

Model Number	MDT2168204
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported there is a concern with the sterile disposable blue operating room towels leaving lint.Additional information received by rn manager, perioperative services, (b)(6), who provided additional information related to this incident.Reporter states, on (b)(6) 2021 during an exploratory laparotomy procedure the sterile disposable blue operating room towel had shed lint into the patient's surgical site.Reporter states, the lint was removed successful via irrigation.Reporter states, no serious injury or impact to the patient occurred.Reporter denies anesthesia time was delayed or impacted.No samples are available for return and evaluation.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 there is a concern with the sterile disposable blue operating room towels leaving lint.

• Brand Name: MEDLINE
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,DLX,4/PK,20PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11300454
• Report Number: 1417592-2021-00013
• Device Sequence Number: 883344
• Product Code: FRL
• UDI-Device Identifier: 20080196834058
• UDI-Public: 20080196834058
• 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): 02/09/2021

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: MDT2168204
• Device Catalogue Number: MDT2168204
• Device Lot Number: 84320040087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/09/2021
• 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: 107