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

Catalog Number	NON21430LF
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a spine fusion, the gauze sponge left loose threads in the surgical site.Per report, irrigation and forceps were utilized to successfully retrieve the threads from the surgical site.The gauze sponge was inspected before use and no issue was identified at that time.The gauze was reportedly unfolded and then folded lengthwise during use in the procedure.General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No patient issues related to the event has been reported at this time.There was no serious injury or need for follow-up care related to this event.Due to the reported event and medical intervention required to retrieve the gauze threads, this medwatch is being filed.The sample is not available to be 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 or Problem Description
It was reported that the gauze sponge left loose threads in the surgical site and irrigation and forceps were used to successfully retrieve these threads from the surgical site.

• Common Device Name: GAUZE,SPONGE,4"X4",16PLY,XRAY,STRL,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8577856
• Report Number: 1417592-2019-00064
• Device Sequence Number: 2349499
• Product Code: GDY
• UDI-Device Identifier: 80080196832346
• UDI-Public: 80080196832346
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NON21430LF
• Device Lot Number: 6051709007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/03/2019
• 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