MAUDE Adverse Event Report: SMITHS MEDICAL STOPCOCK IV SET; 4-WAY STOPCOCK

Lot Number 3276045

Device Problem Crack (1135)

Patient Problem Blood Loss (2597)

Event Date 07/08/2017

Event Type  Injury  

Event Description

Uac stopcock hub cracked.Infant lost 10-15cc of blood.

• Brand Name: STOPCOCK IV SET
• Type of Device: 4-WAY STOPCOCK
• Manufacturer (Section D): SMITHS MEDICAL; dublin OH
• MDR Report Key: 7159823
• MDR Text Key: 96362127
• Report Number: MW5074375
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/28/2017

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
• Device Operator: Health Professional
• Device Lot Number: 3276045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2018
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 5 DA
• Patient Weight: 1