MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX ULTRA SMALL BORE STOPCOCK; FMG - INTRAVASCULAR ADMINISTRATION SET

Catalog Number MX2311L

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

Reference uf/importer # (b)(4).

Manufacturer Narrative

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: MEDEX ULTRA SMALL BORE STOPCOCK
• Type of Device: FMG - INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; dublin OH
• Manufacturer (Section G): SMITHS MEDICAL ASD; 6250 shier-rings rd.; dublin OH 43016
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4290782
• MDR Text Key: 17629744
• Report Number: 2183502-2014-00874
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX2311L
• Was Device Available for Evaluation?: No
• Date Report to Manufacturer: 11/17/2014
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/18/2014
• 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