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

Catalog Number DYNJ67162

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

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 Description

It was reported that the x-ray detectable gauze was shedding gauze material.

• Type of Device: X-RAY DETECTABLE GAUZE IN BACK PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 11474017
• MDR Text Key: 241831749
• Report Number: 1423395-2021-00012
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10193489395969
• UDI-Public: 10193489395969
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention