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

Catalog Number	NON21430LF
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported from the facility that a patient was undergoing a posterior spine fusion and exploration of the spine when the gauze was noted to be fraying in the spine during the procedure.The material had to be picked out by the surgeon and the area was irrigated with no additional intervention required.The patient was under general anesthesia at the time of the event; however there was no reported additional anesthesia required or extension in procedure time required related to the customer reported issue.There is no additional information available.There was no report of any adverse patient consequence, no effect on the patient's stability as a result of the incident.A companion sample was returned to the manufacturer for evaluation and the customer reported issue was confirmed.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.Due to the reported incident, 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 was noted to be fraying in the spine during the procedure and required manual removal during the procedure.

• Common Device Name: GAUZE,SPONGE,4"X4",16PLY,XRAY,STRL,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10415214
• Report Number: 1417592-2020-00056
• Device Sequence Number: 2445703
• Product Code: GDY
• UDI-Device Identifier: 80080196832346
• UDI-Public: 80080196832346
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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: 6051911103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/17/2020
• 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: Required Intervention
• Patient Age: 20 YR