MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOWEL,OR,DSP,ST,WHITE,DLX,XR,4/PK,20PK/C

Catalog Number MDT2168054XR

Device Problems Product Quality Problem (1506); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that operating room (or) towels were linting more than normal and reporting facility "found lint on heart valve." despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause cannot be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that operating room (or) towels were linting more than normal and reporting facility "found lint on heart valve.".

• Type of Device: TOWEL,OR,DSP,ST,WHITE,DLX,XR,4/PK,20PK/C
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7534521
• MDR Text Key: 108934358
• Report Number: 1417592-2018-00040
• Device Sequence Number: 1
• Product Code: FRL
• UDI-Device Identifier: 10080196288373
• UDI-Public: 10080196288373
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MDT2168054XR
• Device Lot Number: 84317060091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other