MAUDE Adverse Event Report: ELCAM MEDICAL ACAL MARVELOUS STOPCOCK FOR IVS; STOPCOCK, I.V. SET

Lot Number 3738837

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

A crack was noted in the antireflux port of the stopcock.Stopcock and tubing changed via sterile technique immediately.Fda safety report id # (b)(4).

• Brand Name: MARVELOUS STOPCOCK FOR IVS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ELCAM MEDICAL ACAL
• MDR Report Key: 10118487
• MDR Text Key: 194120540
• Report Number: MW5094826
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3738837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 DA