MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HIGH PRESSURE TUBING; EXTENSION TUBING

Catalog Number 505314002

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The distributor alleged that a foreign object was identified within the non-sterile tubing during their initial inspection of received product.The device was not sent to a user facility.

Manufacturer Narrative

One device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: HIGH PRESSURE TUBING
• Type of Device: EXTENSION TUBING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 7625199
• MDR Text Key: 112297001
• Report Number: 1721504-2018-00286
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 505314002
• Device Lot Number: H1313208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2018
• 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