MAUDE Adverse Event Report: SMITHS MEDICAL INC. STOPCOCK MANIFOLD; STOPCOCK, MANIFOLD

Lot Number 2574857

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

Rotated stopcock and inner part came out, leaving line open.Changed out drip lines early.No harm to patient.

• Brand Name: STOPCOCK MANIFOLD
• Type of Device: STOPCOCK, MANIFOLD
• Manufacturer (Section D): SMITHS MEDICAL INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 3649603
• MDR Text Key: 4199097
• Report Number: 3649603
• Device Sequence Number: 1
• Product Code: FMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 2574857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2014
• Patient Sequence Number: 1
• Patient Age: 2 YR