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

Model Number	70015015
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3015910259-2022-00001
• Device Sequence Number: 2382144
• Product Code: DTL
• UDI-Device Identifier: 10193489064568
• UDI-Public: 10193489064568
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: 70015015
• Device Catalogue Number: 70015015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown