MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS; HEMOLOK CLIP

Catalog Number 544240

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

Alleged event: they break easily and do not stick when you close the appliers.The patient's condition was reported as unknown.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok l clips 6/cart 84/box, lot #73k1400167 investigation did not show issues related to the complaint.The device sample has been returned to the manufacturer however the investigation report has not been submitted at the time of this report.

Manufacturer Narrative

(b)(4).Nine (9) cartridges of catalog number 544240 hemolok l clips (b)(4) were received not used, closed in original packaging, lot # 73k1400167 was confirmed with samples received.During visual inspection was observed; all components look well assembled.Functional inspection: the (b)(4) clips were closed (closure test) into the appropriate media tubing p/n 06424-66 according to manufacturing procedures (b)(4); the clips were properly/correctly closed, after the closure test the (b)(4) clips were reviewed/verified (pulled) to duplicated the failure mode.No quality issues were found.Samples received did not confirm the defect reported by the customer "not closing" during visual inspection.In addition, a functional inspection was performed with clips received and the device worked properly.Therefore, a corrective action is not required at this time.However, we will continue to monitor for trends.

Event Description

Alleged event: they break easily and do not stick when you close the appliers.The patient's condition was reported as unknown.

• Brand Name: HEMOLOK L CLIPS
• Type of Device: HEMOLOK 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: 4862001
• MDR Text Key: 17632429
• Report Number: 3003898360-2015-00468
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2019
• Device Catalogue Number: 544240
• Device Lot Number: 73K1400167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1