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

Catalog Number MX9341L

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 12/19/2016

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

It was reported that the medex¿ large bore - hi-flo¿ stopcocks disconnected during use.Also, some blood loss from patient was noted.Reporter stated blood sampling was performed which showed decreased hemoglobin (measured at 75g/l, at last check was 88g/l).The patient was given a blood transfusion following the blood loss and drop in hemoglobin.The customer troubleshooted the issue and observed that when you wiggle the stopcock it starts to rotate in the unlocking direction; loosening and eventually becoming unlocked and disconnected.

Manufacturer Narrative

The reported medex¿ large bore - hi-flo¿ stopcock was not returned for investigation; however, a video of the reported issue was provided.Examination of the video found that heavy movement (not typical in clinical applications) could lead to disconnection.As the device was not returned for investigation, the reported issue could not be confirmed and a root cause was not able to be determined.

• Brand Name: MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCKS
• 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: 6260196
• MDR Text Key: 65061913
• Report Number: 3012307300-2017-00196
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: MX9341L
• Device Lot Number: 3273619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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): Required Intervention