MAUDE Adverse Event Report: NAMIC SC 1W LP RC TEE W - PG

Model Number 70015015

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the stopcock was leaking when placed on the patient drain resulting in unnecessary days of hospital stays for the patient.The drain nurse reported that the drains are flushed daily and when the flush syringe is connected to the stopcock the saline 'shoots out the side of the stopcock'.The drain nurse reported that the leaking prolongs the drain staying in the patient and lengthens the patient's recovery time which increased the number of days that the patient was in the hospital.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was not returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the stopcock was leaking during use on a drain potentially increasing the patient's recovery time.No additional information is available.

• Brand Name: SC 1W LP RC TEE W - PG
• Type of Device: SC 1W LP RC TEE W - PG
• Manufacturer (Section D): NAMIC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13982141
• MDR Text Key: 298223927
• Report Number: 3015910259-2022-00001
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 10193489064568
• UDI-Public: 10193489064568
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70015015
• Device Catalogue Number: 70015015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other