MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE,SPONGE,XRAY,4"X4",16PLY,NS,LF

Catalog Number NON25430

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that fibers are falling out into specimen's being sent out, and being picked out of wounds during an unidentified surgery.No specimen related issues were reported.It was further mentioned that this event did not cause harm to the patient.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported required medical intervention to retrieve frayed and loose strings of the gauze sponge from the wound, this medwatch is being filed.No sample returned for evaluation.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that x-ray detectable gauze is coming apart during use.

• Type of Device: GAUZE,SPONGE,XRAY,4"X4",16PLY,NS,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 9799677
• MDR Text Key: 190760228
• Report Number: 1417592-2020-00024
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 10080196752850
• UDI-Public: 10080196752850
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NON25430
• Device Lot Number: 6051907097
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention