MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ DOUBLE Y-CONNECTOR; TUBING, FLUID DELIVERY

Catalog Number MX612-HRV

Device Problems Material Disintegration (1177); Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.

Event Description

It was reported that a medex¿ double y-connector was attached to a patient in the intensive care unit for a noradrenaline infusion when it was observed that the check valve started to leak within 24 hours of use.It was noted that forceps were used to disconnect the infusion and the extension, which caused the bonding material to loosen and disintegrate.No patient injury was reported.See mfr: 3012307300-2017-00834.

Manufacturer Narrative

Two used medex¿ double y-connectors were returned for investigation.The returned devices were received without port protectors, but were otherwise assembled according to the approved drawing.Further observation showed that one valve was broken inside the female luer lock in one of the devices.A cause for the broken valve could be using excessive force when disconnecting the line by using forceps, as the reporter indicated.The connection between the valve and female luer lock is supposed to be glued as per specification, with no screwing in and out available.Connection should be screwed in at the inlet side of the valve.Functional testing was performed and found a visible leak from underneath the check valve.Further observation revealed this valve was broken too but it was still possible to screw in the lock.The complaint was confirmed.The root cause was determined a user interface issue.The user interfaced with the device in a manner that was inconsistent with the instructions for use.

• Brand Name: MEDEX¿ DOUBLE Y-CONNECTOR
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; unit 4 bradwood court st.; 1 crispin way; rossendale, BB4 4 PW; UK BB4 4PW
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6487541
• MDR Text Key: 72659548
• Report Number: 3012307300-2017-00901
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX612-HRV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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