MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. DUALCAP; PAD, ALCOHOL, DEVICE DISINFECTANT

Catalog Number 550-LB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Airway Obstruction (1699); Apnea (1720); Foreign Body In Patient (2687)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the complaint database and device history record could not be performed since the lot number was not provided.

Event Description

A medwatch [mw5074347] was received via u.S.Mail.The account alleges that a patient experienced respiratory/cardiac arrest within the cardiac surgery department post coronary artery bypass graphing [cabg] procedure.The patients progress was complicated by heparin induced thrombocytopenia [hit], disseminated intravascular coagulation [dic] and necrosis of some digits.On unknown date, the patient was assessed by the rn in telemetry and was found to be lethargic.The patient then became apneic, the ecg displayed pea and asystole within the cardiovascular intensive care unit.A code blue was initiated.A bronchoscopy was then ordered and performed upon arrival in the intensive care unit.A foreign body consistent with a light blue dual cap medical device [per md note] was extracted.The patient was extubated on unknown date and is currently awaiting transfer back to the telemetry unit.

• Brand Name: DUALCAP
• Type of Device: PAD, ALCOHOL, DEVICE DISINFECTANT
• 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: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 7261517
• MDR Text Key: 99769351
• Report Number: 1721504-2018-00011
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 550-LB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention