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

Catalog Number MX2311L

Device Problem Component(s), broken (1103)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The reporter stated that the device became disassembled during use.The drip lines in use at the time were replaced.There was no reported pt injury or treatment associated with this event.

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.Method: a sample device was returned and is currently under investigation.

• Brand Name: ULTRA THREE-WAY STOP COCK W/SWIVEL 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 gey road; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3810464
• MDR Text Key: 19717320
• Report Number: 2183502-2014-00214
• 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: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: MX2311L
• Device Lot Number: 2601490
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1