MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON H-V FILTER COMPACT W/EXPANDI-FLEX, STERI

Catalog Number G19611

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

The event is reported as: the filter dislocated in two parts at the level of the blue mark.

Manufacturer Narrative

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

• Brand Name: HUDSON H-V FILTER COMPACT W/EXPANDI-FLEX, STERI
• Type of Device: H-V FILTER
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC
• Manufacturer (Section G): TELEFLEX MEDICAL; p.o. box 28
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4142722
• MDR Text Key: 16305548
• Report Number: 8040412-2014-00218
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G19611
• Device Lot Number: 13KT21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2014
• 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
• Patient Age: 56 YR