MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS

Catalog Number 544230

Device Problem Unsealed Device Packaging (1444)

Patient Problem Not Applicable (3189)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box, lot number 73m1400155 investigation did not show issues related to the complaint.The device sample has not been returned for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: a cartridge was not sealed.The issue was identified prior to patient use.

Manufacturer Narrative

(b)(4).One (1) cartridge of catalog number 544230 hemolok ml clips 6/cart 84/box was received not used, lot # 73m1400155 was confirmed.During visual inspection the packaging was unsealed (tyvek & web have no sealing marks).An evaluation was performed under the engineering test request form; (b)(4), which consists at verifying the multivac # 6 identified as mt-971 can detect the package without seal during a normal run of production.Sample received confirmed the defect reported by the customer breach of sterile barrier during visual inspection.As part of the investigation the potential root cause of this defect could be the machine technician deactivated the station of pre-sealing and sealing during the set up the machine.As part of the actions order engineering (b)(4) was opened to document in the corresponding forms that the machine technician must verify and document the functions; detector holes, pre-stamped & sealed are activated.In addition, production personnel will notified about the issue.

Event Description

Alleged event: a cartridge was not sealed.The issue was identified prior to patient use.

• Brand Name: HEMOLOK ML CLIPS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5046163
• MDR Text Key: 25304370
• Report Number: 3003898360-2015-00580
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Technologist
• Type of Report: Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2019
• Device Catalogue Number: 544230
• Device Lot Number: 73M1400155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1