MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE IN LAG MINOR PROCEDURE TRAY

Catalog Number	DYNJ901880D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an inguinal hernia repair, gauze shredding contacted the surgical site.The gauze shredding was successfully removed from the surgical site through use of forceps.Immediately after the incident, all gauze from the surgical field were removed and a new package of raytec sponges were opened.No impact to the patient, the procedure, or the total length of the procedure was reported.There was no serious injury reported related to this event.Due to the reported event and need to retrieve the gauze shredding from the surgical site, this medwatch is being filed.The samples were returned for evaluation.The returned samples of gauze were noted to be unfolded by the user beyond the first fold, which likely resulted in the loose threads and the appearance of shredding.User error was determined to be the root cause for gauze shredding.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the gauze was shredding and this reached the surgical site.The shredding was successfully removed from the surgical site through use of forceps.

• Common Device Name: GAUZE IN LAG MINOR PROCEDURE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8506042
• Report Number: 1423395-2019-00009
• Device Sequence Number: 19294475
• Product Code: LRO
• UDI-Device Identifier: 10889942974344
• UDI-Public: 10889942974344
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: DYNJ901880D
• Device Lot Number: 18LBH633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/11/2019
• 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