MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ HI-FLO¿ STOPCOCK; STOPCOCK, I.V. SET

Catalog Number MX9341L

Device Problem Mechanical Problem (1384)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/15/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch form #: mw5066816.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a medex hi-flo stopcock had its "yellow swivel/directional" blow apart.The issue occurred when the radiologist mixed a gelfoam slurry.It was initially reported that the product did not reach the patient, but then it was reported that the event led to a serious injury.It was unclear what the impact to a patient was.See mfr: 3012307300-2017-00486 and 3012307300-2017-00487.

• Brand Name: MEDEX¿ HI-FLO¿ STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 6250 shier rings road,; dublin OH 43016
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6312290
• MDR Text Key: 66826189
• Report Number: 3012307300-2017-00485
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MX9341L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability