MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; X-RAY DETECTABLE GAUZE IN BACK PACK

Catalog Number	DYNJ67162
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, during an unspecified procedure, the x-ray detectable (xrd) gauze was shedding gauze material into the surgical site.The gauze material was able to be retrieved from the surgical site by the surgeon and no further procedure-related incident was reported.There was no adverse patient impact and there was no need for follow-up care related to the reported xrd gauze issue.A sample of unused gauze only was returned for evaluation.No surgical pack was received.Upon physical inspection of the received sample, no physical damage was noted.A product-related root cause was unable to be determined.Due to the reported need for medical intervention to retrieve gauze material from the surgical site, 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 x-ray detectable gauze was shedding gauze material.

• Common Device Name: X-RAY DETECTABLE GAUZE IN BACK PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11474017
• Report Number: 1423395-2021-00012
• Device Sequence Number: 11504599
• Product Code: OJH
• UDI-Device Identifier: 10193489395969
• UDI-Public: 10193489395969
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: DYNJ67162
• Device Lot Number: 20HBJ458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/12/2021
• 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