MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline Industries, Inc.; GAUZE IN GEN LAPAROSCOPY PACK

Model Number	DYNJ46051A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the gauze was identified to be shredding during an unidentified procedure.Reportedly, gauze material was required to be retrieved from the patient.Despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the manufacturer.No adverse patient impact was originally reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention to retrieve gauze material from the patient, 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 gauze component was identified to be shredding.

• Brand Name: Medline Industries, Inc.
• Common Device Name: GAUZE IN GEN LAPAROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9789757
• Report Number: 1423395-2020-00004
• Device Sequence Number: 561256
• Product Code: FDE
• UDI-Device Identifier: 10889942185528
• UDI-Public: 10889942185528
• Combination Product (Y/N): N
• 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): 03/04/2020

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 Model Number: DYNJ46051A
• Device Catalogue Number: DYNJ46051A
• Device Lot Number: 19JMB490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/04/2020
• 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