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

Catalog Number K12T-08232

Device Problem Air Leak (1008)

Patient Problem ST Segment Elevation (2059)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

The affected device has not yet been returned for evaluation.A follow up report will be submitted when the evaluation has been completed.

Event Description

The user reported that air leaked into the system and was injected into the patient.The patient experienced st elevation which resolved in approximately 20 minutes.No intervention was required.No further patient harm or injury was reported.

Manufacturer Narrative

One device was returned for evaluation.The unit was tested and the reported defect could not be duplicated.The failure could not be confirmed.A review of the device history record and complaint database could not be performed since the lot number was not provided.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM 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: 5354546
• MDR Text Key: 35463037
• Report Number: 9616662-2016-00002
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K913682
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K12T-08232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Life Threatening