MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; OR TOWEL IN OPEN HEART CDS

Catalog Number	CDS985340A
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the operating room (or) towel was shedding lint during an unidentified vascular procedure.The linted or towel material was found on several instruments and "floating in air above the surgical site." or towel linting into the surgical site was not reported.The patient was under general anesthesia at the time of this incident.The unidentified vascular procedure did not last longer than expected.The patient did not require additional anesthesia during this incident.No impact to the patient, to the patient's stability, or to the procedure during the incident was noted at the time of the initial report.No serious injury or medical intervention during the incident was noted at the time of the initial report.After an unidentified period of time, the patient reportedly returned to the facility with a surgical site infection (ssi) and, according to the facility, the linting of the operating room (or) towel could not be ruled out as a possible root cause of the ssi.No additional information was provided on the diagnostic exams performed leading to the diagnosis of the ssi or the treatment that was required following the ssi diagnosis.A sample was returned to the manufacturer for evaluation and the reported product issue was confirmed.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the operating room (or) towel was shedding lint during an unidentified vascular procedure.After an unidentified period of time, the patient reportedly returned with a surgical site infection.

• Common Device Name: OR TOWEL IN OPEN HEART CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7529627
• Report Number: 1423395-2018-00030
• Device Sequence Number: 19220087
• Product Code: OEZ
• UDI-Device Identifier: 10889942661060
• UDI-Public: 10889942661060
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: CDS985340A
• Device Lot Number: 18BB1519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/21/2018
• 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: Other