MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE,SPONGE,8"X4",24PLY,XRAY,STRL,LF

Catalog Number	NON21438
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the gauze sponge was identified to be "pulling apart" and that gauze material was found "in the wound of 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 identification of foreign particulate in the wound of the patient, and in an abundance of caution, 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 sponge was identified to be "pulling apart.".

• Common Device Name: GAUZE,SPONGE,8"X4",24PLY,XRAY,STRL,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9591506
• Report Number: 1417592-2019-00235
• Device Sequence Number: 2500365
• Product Code: GDY
• UDI-Device Identifier: 10080196841752
• UDI-Public: 10080196841752
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/15/2020

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 Catalogue Number: NON21438
• Device Lot Number: 6051812067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 01/15/2020
• 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: Other