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

Catalog Number MX5311L

Device Problem Infusion or Flow Problem (2964)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.There are two lot numbers that could be associated with this complaint lot numbers 3125601 and 3153895.

Event Description

This event occured in (b)(6).Customer stated that a patient in the mri required levophed for blood pressure support due to the blood pressure dropped requiring the rn to increase levophed infusion rate.This was performed 3 times by rn with no effect on blood pressure and it continued to drop.Rn screened and cleared to go into mri to problem solve.Rn found stopcock had been accidently turned off & white lever was coming off.Rn turned on unit and pushed down white lever.The patient's blood pressure went high due to rate of medication infusing.Do to mri process taking awhile, other icu patients mri's postponed.

Manufacturer Narrative

The reported 3-way stopcock with swivel male luer lock was returned for investigation.A visual and photographic investigation was performed.Based on the condition of the devices it was concluded that the clinical person using the product turned the handle in a direction not intended based on its design.Root cause was determined to be customer misuse of the product.

• Brand Name: MEDEX¿ SMALL BORE STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5749286
• MDR Text Key: 48188326
• Report Number: 2183502-2016-01250
• 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: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention