MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC MERIT MANIFOLD

Catalog Number 503HN-R/CN

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

The affected device has not yet returned for evaluation.A follow up report will be submitted for evaluation.

Event Description

The user reported that the device was delivered with a defect in the sterile barrier.

Manufacturer Narrative

One device was returned for evaluation.The device was visually inspected and a defect in the packaging material was observed.The complaint is confirmed.The root cause of the failure was a force applied to the manifold forcing it through the packaging material.The defect was large enough to be easily seen and located near the end the package is opened.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and one similar complaint for this lot number was found.

• Brand Name: MERIT MANIFOLD
• Type of Device: MANIFOLD
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5365335
• MDR Text Key: 36280567
• Report Number: 1721504-2016-00008
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K913161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 503HN-R/CN
• Device Lot Number: H787906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1