MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX HI-FLOW STOPCOCKS; STOPCOCK IV SET

Model Number MX9341L

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that the nicu nurse noticed a cracked hub in the umbilical line tubing setup.Blood was noted backing up into the umbilical line throughout the shift.When the nurse found a large crack at 4am, the tubing was changed.It appeared that the cracked component was from the 3 way stopcock.No harm to the patient was reported.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Therefore, the complaint has been confirmed.It appears that the crack was likely caused by overtightening the locknut due to the curvature of the stress cracking seen on both the locknut and the stopcock body.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: MEDEX HI-FLOW STOPCOCKS
• Type of Device: STOPCOCK IV SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16269200
• MDR Text Key: 308563807
• Report Number: 3012307300-2023-00733
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504173
• UDI-Public: 10351688504173
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: MX9341L
• Device Catalogue Number: MX9341L
• Device Lot Number: 3943567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Female