MAUDE Adverse Event Report: TELEFLEX AUTO ENDO5 ML; HEMOCLIPS

Catalog Number 543965

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

Alleged event: during an intervention the clips did not close properly.No reported pt injury.

Manufacturer Narrative

The device history report (dhr) indicates that the product auto endo5 ml, lot # 01m1300260 was manufactured on 12/17/2013 a total of (b)(4) pieces.Lot was released on 12/19/2013.Dhr investigation did not show issues related to complaint.The device sample was not received by the mfr at the time of this report.The mfr will continue to monitor and trend related complaints.

• Brand Name: AUTO ENDO5 ML
• Type of Device: HEMOCLIPS
• Manufacturer (Section D): TELEFLEX; tecate, b.c. ; MX
• Manufacturer Contact: effie jefferson, rn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 4001272
• MDR Text Key: 4688729
• Report Number: 3003898360-2014-00466
• Device Sequence Number: 1
• Product Code: MCH
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 543965
• Device Lot Number: 01M1300260
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1