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

Catalog Number MX43660

Device Problem Fracture (1260)

Patient Problem Venipuncture (2129)

Event Type  Injury  

Event Description

User facility reported that during manipulation of the moveable piece to draw a blood sample it dislodged from the clear plastic portion of the stopcock.This resulted in the iv being dislodged and requiring new iv placement.

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

• Brand Name: ULTRA THREE-WAY STOPCOCK W/MALE LUER LOCK
• Type of Device: FMG-STOPCOCKS AND MANIFOLDS
• Manufacturer (Section D): SMITHS MEDICAL, 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: 4707497
• MDR Text Key: 5719296
• Report Number: 2183502-2015-00217
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX43660
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other