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

Catalog Number DYNJ57161

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2018

Event Type  malfunction  

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 Description

It was reported that "fuzz" was found on the lap sponge and the "fuzz" ended up inside of the patient.

• Type of Device: LAP SPONGE FROM TOTAL JOINT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 7931089
• MDR Text Key: 122634937
• Report Number: 1423395-2018-00053
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942725427
• UDI-Public: 10889942725427
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other