MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-GARD FILTER STRAIGHT

Catalog Number G19212

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges a leak in the anesthetic machine.The customer reports that the source of the leak was a sliver of plastic which was between two connectors preventing them from connecting.The alleged issue was detected prior to patient use.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of the report.

• Brand Name: HUDSON ISO-GARD FILTER STRAIGHT
• Type of Device: FILTER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; p.o. box 28
• Manufacturer Contact: margie burton, rn, reg affairs ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3915392
• MDR Text Key: 4489520
• Report Number: 8040412-2014-00117
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G19212
• Device Lot Number: 19212T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1