MAUDE Adverse Event Report: MEDLINE INDUSTRIES (NAMIC DIVISION) NAMIC; NAMIC CONVENIENCE KIT-LEFT HEART

Model Number H96565190784

Device Problems Unable to Obtain Readings (1516); Defective Device (2588)

Event Date 01/20/2022

Event Type  malfunction  

Event Description

2 manifolds in the cardio cath packs were defective and would not give proper pressure readings.Multiple attempts were made to check the transducer from different channels.No harm to patient.Defective items were not saved due to bodily fluid contamination.

Manufacturer Narrative

The left heart kit was contained, as a component, within an roi cps, llc convenience kit.(item 800222010, lot 86762j).

• Brand Name: NAMIC
• Type of Device: NAMIC CONVENIENCE KIT-LEFT HEART
• Manufacturer (Section D): MEDLINE INDUSTRIES (NAMIC DIVISION); 10 glens falls; ny NY 12801
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176472305
• MDR Report Key: 13425568
• MDR Text Key: 287184781
• Report Number: 3014527682-2022-00004
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K782095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Report Date: 02/02/2022

1 Device was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H96565190784
• Device Catalogue Number: 65190784
• Device Lot Number: 5651008, 5654476, 5658652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• 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: Initial