MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; LAP SPONGE FROM TOTAL JOINT PACK

Catalog Number	DYNJ57161
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "fuzz" was found on the lap sponge and the "fuzz" ended up inside of 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.No information was provided on exactly where within the lap sponge the "fuzz" was found and what medical intervention was required to retrieve the "fuzz" from the patient.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The lap sponge was not returned for evaluation.A sample of a piece of cotton-like material approximately ½-inch long was returned in a specimen cup for evaluation.A 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 "fuzz" was found on the lap sponge and the "fuzz" ended up inside of the patient.

• Common Device Name: LAP SPONGE FROM TOTAL JOINT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7931089
• Report Number: 1423395-2018-00053
• Device Sequence Number: 1473155
• Product Code: OJH
• UDI-Device Identifier: 10889942725427
• UDI-Public: 10889942725427
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ57161
• Device Lot Number: 18FBI435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/03/2018
• 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: Other