MAUDE Adverse Event Report: TELEFLEX HUDSON STYLET, SOFT TIP, 6 FR

Catalog Number 5-15120

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the intubating stylet presents a tip perforated by a protruding metallic part.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.The dhr (device history record) for the reported lot number was reviewed and showed no issues related to the complaint.A document assessment (fmea) was conducted and no changes were required.

• Brand Name: HUDSON STYLET, SOFT TIP, 6 FR
• Type of Device: STYLET
• Manufacturer (Section D): TELEFLEX; rpt NC
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4099022
• MDR Text Key: 4702514
• Report Number: 3003898360-2014-00659
• Device Sequence Number: 1
• Product Code: BSR
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5-15120
• Device Lot Number: 01M1300072
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1