MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET

Catalog Number MX5311L

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/18/2015

Event Type  Injury  

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.

Event Description

During use of two of the listed devices in line with a right femoral dl cvl - the cvp port, it was noted that one of the stopcocks white knobs had popped out a few mm and would not lock into place.Clinician was unable to put the knob back in and stopcock had to be replaced.During this event, patient's blood pressure lowered and required escalated treatment, multiple fluid and electrolyte boluses administered during change of stopcock.No adverse health outcome resulted from this event.

• Brand Name: MEDEX SMALL BORE STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5332950
• MDR Text Key: 34638463
• Report Number: 2183502-2015-01004
• 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: Other
• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX5311L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• 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
• Patient Outcome(s): Other