MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON H-V FILTER SMALL STRAIGHT, STERILE

Catalog Number G19501

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

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer reports that the package is torn.The reported issue was detected during incoming inspection by the dist (imj).

Manufacturer Narrative

The device sample was returned to the mfr, but the investigation is incomplete at the time of this report.

• Brand Name: HUDSON H-V FILTER SMALL STRAIGHT, STERILE
• Type of Device: H-V 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: 3851583
• MDR Text Key: 4654728
• Report Number: 8040412-2014-00077
• 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: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G19501
• Device Lot Number: 13JT03J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1