MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; GAUZE IN MINOR PROCEDURE PACK

Catalog Number	DYNJ44989F
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "the gauze came apart while in the patient." it is unknown how the gauze was found or removed from the surgical site.Although a number of attempts were made to attempt to obtain additional information, the account did not provide any further details regarding this incident.The actual sample was returned for evaluation.The edges of the gauze that seemed to be attached to each other at one point were frayed and some of the threads were no longer woven together indicating a possibility that the gauze was cut, but a definitive root cause could not be determined with the sample provided.No injury or further intervention was reported.However, due to the reported incident and in an abundance of caution, this medwatch is being filed.
Event or Problem Description
The facility reported that the gauze came apart today while in the patient.

• Common Device Name: GAUZE IN MINOR PROCEDURE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; three lakes dr; northfield IL 60093
• MDR Report Key: 6995956
• Report Number: 1423395-2017-00026
• Device Sequence Number: 1183963
• Product Code: FDE
• UDI-Device Identifier: 10889942547753
• UDI-Public: 10889942547753
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2017

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
• Operator of Device: Physician
• Device Catalogue Number: DYNJ44989F
• Device Lot Number: 17RB6679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 11/02/2017
• 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