MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS; DRAPE, SURGICAL

Model Number MDT2168286

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

Opened product case to restock.Found an unknown liquid within the plastic liner of the case where the product is.

• Brand Name: TOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 15378246
• MDR Text Key: 299458756
• Report Number: 15378246
• Device Sequence Number: 1
• Product Code: KKX
• UDI-Device Identifier: 20080196282743
• UDI-Public: (01)20080196282743
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022,08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MDT2168286
• Device Catalogue Number: MDT2168286
• Device Lot Number: 6052204021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1