MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. PRE-AMP CABLE, MPM-1, CONNECTS MONITOR TO CATHET

Catalog Number PAC1

Device Problems Connection Problem (2900); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

A pac1 pre amp cable was found to have foreign material on the inside of a connector and it could not be connected.The issue was found upon inspection, therefore there was no patient involvement.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: PRE-AMP CABLE, MPM-1, CONNECTS MONITOR TO CATHET
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire ; UK
• Manufacturer Contact: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 4223708
• MDR Text Key: 4974404
• Report Number: 8010219-2014-00037
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAC1
• Device Lot Number: 540723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/05/2014
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1