MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE IN DBD-MINOR PK

Catalog Number	DYNJ58845
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in the middle of a breast lumpectomy, gauze fiber was found to have linted into the surgical site.The surgeon was required to remove the linted gauze fiber with forceps and the surgical site was irrigated.The patient was under general anesthesia at the time of the incident.The procedure did not last longer than expected and the patient did not require additional anesthesia.The procedure was completed without further reported incident.No impact to the patient or the patient's stability reported.No serious injury or follow-up care reported.A sample of gauze fibers only were returned to the manufacturer.Neither the gauze nor the surgical pack were returned to the manufacturer for evaluation.A root cause could not be determined.Due to the need for medical intervention to remove the linted gauze fiber from the surgical site, this medwatch is being filed.If additional information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that in the middle of a breast lumpectomy, gauze fiber was found to have linted into the surgical site.

• Common Device Name: GAUZE IN DBD-MINOR PK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7942940
• Report Number: 1423395-2018-00051
• Device Sequence Number: 1381347
• Product Code: FDE
• UDI-Device Identifier: 10889942898985
• UDI-Public: 10889942898985
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ58845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/08/2018
• 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: 46 YR