MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE IN BASIN SET KIT

Catalog Number	DYNJ38849D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was originally reported to the manufacturer on (b)(6) 2019 that the gauze component was identified to be shredding and that the reporting facility was concerned that gauze material may lint into a surgical site.On (b)(6) 2019, the manufacturer received a medwatch (mw5083299) indicating that during an unidentified procedure, gauze material was actually found to have linted into the surgical site.It was not identified how the gauze component was being used at the time of the incident.Reportedly, the gauze material was removed from the surgical site with forceps.The patient was under general anesthesia at the time of the incident.The patient did not require additional anesthesia to complete the unidentified procedure.There was no impact or adverse effect to the patient, the patient's stability, or to the unidentified procedure in relation to the reported incident.The sample involved in the reported incident was returned to the manufacturer for evaluation.The gauze was balled up and appeared to have been opened all the way.Gauze that is opened past the second fold will have its edges exposed and is more susceptible to fraying.User error was identified to have caused and/or contributed to the reported product issue.Due to the need for medical intervention to remove the gauze material from the surgical site, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that during an unidentified procedure, gauze material was identified in the surgical site.

• Common Device Name: GAUZE IN BASIN SET KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8341323
• Report Number: 1423395-2019-00002
• Device Sequence Number: 2284419
• Product Code: LRO
• UDI-Device Identifier: 10889942966998
• UDI-Public: 10889942966998
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/14/2019

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 Catalogue Number: DYNJ38849D
• Device Lot Number: 18JBI801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/14/2019
• 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: 85 YR
• Patient Weight: 96