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

Catalog Number	MDT2168204
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that use of forceps and irrigation was required to successfully retrieve from the surgical sites the blue fibers coming from linting or towels.Per report, the reported incidents happened during an unknown number of multiple various surgical procedures.General anesthesia was used; however, there was no report of any adverse patient consequences and no effect on the patients' stability as a result of the incidents.No impact to the patients, the procedures, or the total length of the procedures was reported.There was no serious injury or follow-up care reported related to this event.Due to the reported medical intervention and in an abundance of caution, this medwatch is being filed.The sample has been discarded and was not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, this report will be reopened and re-evaluated.
Event or Problem Description
It was reported that use of forceps and irrigation was required to successfully retrieve the pieces of blue fibers coming from linting or towels.

• 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: 7806241
• Report Number: 1417592-2018-00094
• Device Sequence Number: 1747584
• Product Code: FRL
• UDI-Device Identifier: 20080196834058
• UDI-Public: 20080196834058
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: Health Professional
• Device Catalogue Number: MDT2168204
• Device Lot Number: 6051711002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: Required Intervention