MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNK DUMMY MATERIAL; HEMOCLIP LARGE UNK

Catalog Number SURGICAL UNK

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 03/21/2014

Event Type  Death  

Event Description

Alleged issue: customer reported that they took their german shepherd to be spayed, but death occurred due to bleeding after the surgery, because the hemoclip came off.The vet stated that a hemolok ligating clip was used.

Manufacturer Narrative

(b)(4).Device history record (dhr) review could not be conducted since the lot number was not provided.Failure mode "clip slipped off vessel" was unable to be confirmed with the picture that was submitted by the customer.Customer complaint cannot be confirmed due to lack of product sample to perform a proper investigation and determine the root cause.However, the manufacturer will continue to monitor and trend relating complaints.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

• Brand Name: SURGICAL UNK DUMMY MATERIAL
• Type of Device: HEMOCLIP LARGE UNK
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; po box 12600; rtp, NC 27709 ; 9193614124
• MDR Report Key: 4245040
• MDR Text Key: 4989169
• Report Number: 3003898360-2014-00895
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death