MAUDE Adverse Event Report: TELEFLEX HORIZON TI MED 6/CART; HEMOCLIPS

Catalog Number 002200

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Alleged event: the clips fell off a vessel in the thigh.The patient's condition is reported as fine.

Manufacturer Narrative

No sample is available for the manufacturer to evaluate at the time of this report.A device history record review (dhr) review could not be conducted since the lot number was not provided.The manufacturer will continue to monitor and trend related complaints.

• Brand Name: HORIZON TI MED 6/CART
• Type of Device: HEMOCLIPS
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: effie jefferson, rn ; p.o. box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 3960563
• MDR Text Key: 4560923
• Report Number: 3003898360-2014-00409
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 002200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1