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

Catalog Number 203BN-R

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleged that air entered the manifold and connected devices during the procedure.No air was injected into the patient.

Manufacturer Narrative

The suspect device was returned for evaluation and examined visually.The complaint is confirmed.The root cause could not be determined.A review of the complaint database was performed and additional related complaints for this lot number were found from the same customer.A review of the device history record was performed and no exception documents were found.

• Brand Name: MERIT MANIFOLD
• Type of Device: MANIFOLD
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan 84095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan 84095
• MDR Report Key: 6748701
• MDR Text Key: 81295162
• Report Number: 1721504-2017-00153
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K913161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 203BN-R
• Device Lot Number: H1104040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1