MAUDE Adverse Event Report: MEDLINE INDUSTRIES CUSZTOM NEURO PACK; STERILE DRAPES

Model Number DYNJ49357A

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

Patient Problem No Information (3190)

Event Date 04/20/2018

Event Type  malfunction  

Event Description

The patient for a diagnostic cerebral angiogram.Lint from disposable towels on neuro.Tray was found on the wire at the completion of the procedure.

• Brand Name: CUSZTOM NEURO PACK
• Type of Device: STERILE DRAPES
• Manufacturer (Section D): MEDLINE INDUSTRIES
• MDR Report Key: 7494334
• MDR Text Key: 107698988
• Report Number: MW5077071
• Device Sequence Number: 1
• Product Code: KKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ49357A
• Device Catalogue Number: DYNJ49357A
• Device Lot Number: 17LB7274
• 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
• Patient Age: 56 YR