MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MINOR PACK

Catalog Number	DYNJ0843099D
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that toward the end of an unknown procedure a blue string from the x-ray detectable gauze was found in the surgical site.The surgeon was required to remove the blue string from the surgical site via an unknown method.No other information has been provided.Despite multiple good faith efforts to obtain additional information, the initial reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.The reported sample was discarded and was not available to be returned to the manufacturer for evaluation.Due to the need for additional medical intervention to remove the reported blue string from the surgical site, 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 toward the end of an unknown procedure a blue string from the x-ray detectable gauze was found in the surgical site.

• Common Device Name: MINOR PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7343318
• Report Number: 1423395-2018-00010
• Device Sequence Number: 10778620
• Product Code: FDE
• UDI-Device Identifier: 10889942275489
• UDI-Public: 10889942275489
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJ0843099D
• Device Lot Number: 17JK1966
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/15/2018
• 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