MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. ULTRA THREE-WAY STOPCOCK W/SWIVEL MALE LUER LOCK; FMG - STOPCOCKS AND MANIFOLDS

Model Number N

Device Problem Component(s), broken (1103)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

User facility reported that the listed device became disassembled during use.The extension set and stopcock in use at the time were disconnected and replaced.There were no adverse effects to patient reported.

Manufacturer Narrative

Manufacturer completed the entire form.Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: ULTRA THREE-WAY STOPCOCK W/SWIVEL MALE LUER LOCK
• Type of Device: FMG - STOPCOCKS AND MANIFOLDS
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; dublin OH
• Manufacturer (Section G): SMITHS MEDICAL; 6250 shier-rings road; dublin OH 43016
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3952193
• MDR Text Key: 4644099
• Report Number: 2183502-2014-00294
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N
• Device Catalogue Number: MX2311L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2014
• Distributor Facility Aware Date: 04/09/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1