MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE DELUXE BLUE O.R. TOWEL; FIBER, MEDICAL, ABSORBENT

Model Number MDT2168204

Device Problem Contamination (1120)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2023

Event Type  Injury  

Event Description

Excessive lint on medline sterile or(operating room) towels, which got into patient's bloodstream during catheterization procedure.Reference report mw5118915.

• Brand Name: MEDLINE DELUXE BLUE O.R. TOWEL
• Type of Device: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 17225297
• MDR Text Key: 318212048
• Report Number: MW5118916
• Device Sequence Number: 1
• Product Code: FRL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT2168204
• Device Catalogue Number: MDT2168204
• Device Lot Number: 26023010011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male