MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HIGH PRESSURE TUBING KIT

Catalog Number K04-MZL6505

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The distributor reported a foreign object inside the fluid path of the rotator.This was identified during their initial inspection of received product.The device was not sent to a user facility.

• Brand Name: HIGH PRESSURE TUBING KIT
• Type of Device: HIGH PRESSURE TUBING KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer Contact: katie swenson, cqe, cba, cqpa ; 1600 w merit parkway; south jordan 84095 ; 8012081600
• MDR Report Key: 8923056
• MDR Text Key: 157719366
• Report Number: 1721504-2019-00067
• Device Sequence Number: 1
• Product Code: OJA
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: K04-MZL6505
• Device Lot Number: H1512907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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