MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CUSTOM MANIFOLD KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number K09-02334

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2016

Event Type  malfunction  

Event Description

During heart catheterization, the dye chamber would not keep refilling itself and had to be manually refilled multiple times.Air was caught before entering the patient and there was no harm to the patient.Manufacturer response for iv tubing, merit custom manifold kit (per site reporter): this frequently occurring problem was reported by clinical manager of cath lab.Merit confirmed other facilities have had similar problems and a voluntary recall of certain lot numbers will be instituted.

• Brand Name: CUSTOM MANIFOLD KIT
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 5913374
• MDR Text Key: 53456758
• Report Number: 5913374
• Device Sequence Number: 0
• Product Code: DTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: K09-02334
• Device Lot Number: H964179
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Age: 51 YR
• Patient Weight: 101