MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNKNOWN DUMMY MATERIAL; UNKNOWN MED TITANIUM CLIP

Catalog Number SURGICAL UNKNOWN

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

Alleged issue per medwatch: patient had 2 clips off the vein branch of the saphenous vein to the right coronary artery.These were clipped and hemostasis was controlled.We do not have the lot number for this exact product.Additional info: (b)(6) male came in for coronary bypass grafting x4 on (b)(6) 2015.Pt tolerated the procedure well and was transferred to icu.On (b)(6) 2015 the patient coded in icu and a hemoglobin of 5 was found.The patient was taken back to the or.The findings were that the patient had 2 clips off the vein branch of the saphenous vein to the right coronary artery.These were clipped and hemostasis was controlled.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).A device history record (dhr) review could not be conducted since the lot number was not provided.No corrective actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause.The manufacturer will continue to monitor and trend relating complaints.

• Brand Name: SURGICAL UNKNOWN DUMMY MATERIAL
• Type of Device: UNKNOWN MED TITANIUM CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4826887
• MDR Text Key: 5839707
• Report Number: 3003898360-2015-00414
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR