MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON H-V FILTER SMALL STRIGHT, STERILE; H-V FILETER

Catalog Number G19501

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

The event was reported as: the package is torn/broken.The reported issue was detected/reported by distributor ((b)(4)).A total of two device were reported with this issue.

Manufacturer Narrative

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

• Brand Name: HUDSON H-V FILTER SMALL STRIGHT, STERILE
• Type of Device: H-V FILETER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; p.o. box 28; perak ; MY
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3966478
• MDR Text Key: 16544302
• Report Number: 8040412-2014-00154
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G19501
• Device Lot Number: 13KT24J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1