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

Model Number	MDT2168204
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2023 during a left varicolectomy/spermatic cord denervation, hydrocele removal, spermatic cord and hydrocele exploration "lint on towels seen with a microscope by the surgeon".The towels were being used to drape the site.The fibers were reported to not be in the surgical site, however the "area was irrigated by the md", according to the customer.The customer reports, the towels were discarded.The procedure was completed and the patient was seen by pcp in february with no issues reported.There is no sample available to be returned.A root cause could not be established.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
Or towel linting.

• Brand Name: Medline
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,DLX,4/PK,20PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16464083
• Report Number: 1417592-2023-00085
• Device Sequence Number: 3126337
• Product Code: FRL
• UDI-Device Identifier: 20080196834058
• UDI-Public: 20080196834058
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/01/2023

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
• Device Model Number: MDT2168204
• Device Catalogue Number: MDT2168204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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