MAUDE Adverse Event Report: MEDLINE INDUSTRIES MEDLINE CATH PACK; CATHETER LAB PACK

Lot Number 18HBB224

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

Patient Problem No Information (3190)

Event Date 09/20/2018

Event Type  malfunction  

Event Description

Was setting a table using the medline cath pack and noticed debris in the bowl and on the 4x4s.Supplies were pulled from the table and taken to risk mgmt, the rest of the pack was discarded.The lot number is 18hbb224.The package insert was included with the supplies that were taken to risk mgmt.

• Brand Name: MEDLINE CATH PACK
• Type of Device: CATHETER LAB PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES
• MDR Report Key: 7914186
• MDR Text Key: 122151754
• Report Number: MW5080149
• Device Sequence Number: 0
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 18HBB224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1