MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD. MERIT CONVENIENCE KIT

Catalog Number K12T-07796A

Device Problem Air Leak (1008)

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

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

No device is expected to be returned.The evaluation is in process.A follow up report will be submitted when the evaluation has been completed.

Event Description

The user reported that air leaked into the system through the manifold.The air was discovered before it was injected into the patient.No harm or injury to the patient was reported.

Manufacturer Narrative

No device is expected to be returned for evaluation.Because the unit was not returned a formal investigation of the affected device could not be completed and the root cause could not be determined.If the device is returned in the future this investigation will be reopened and a follow up submitted.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.

• Brand Name: MERIT CONVENIENCE KIT
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5262941
• MDR Text Key: 32793047
• Report Number: 9616662-2015-00017
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• 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: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: K12T-07796A
• Device Lot Number: K845539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• 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