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

Model Number	MDT2168284
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2023 "a blue operating room towel was grabbed during an open general surgery procedure to dry off the light cover and debris was falling from the light onto the surgical field".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 "a blue operating room towel was grabbed during an open general surgery procedure to dry off the light cover and debris was falling from the light onto the surgical field".Per the facility "there was excessive lint coming off of the towel and the sterile field had to be fully broken-down and a new setup was required".Per the facility the patient was prescribed an extended round of antibiotics per consultation with infectious disease".No additional information is available at this time.The sample was returned for evaluation, however, a definitive root cause could not be determined at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Brand Name: Medline
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,STD,4/PK,20PK/CS
• 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: 16843613
• Report Number: 1417592-2023-00194
• Device Sequence Number: 20548256
• Product Code: FRL
• UDI-Device Identifier: 10080196282739
• UDI-Public: 10080196282739
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/01/2023

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: MDT2168284
• Device Catalogue Number: MDT2168284
• Device Lot Number: 6052204072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown