MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX 4-WAY STOPCOCK; STOPCOCK I.V. SET

Catalog Number MX9341L

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

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

Event Date 02/03/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone is unknown; no information has been provided to date.G5: 510k is blank, device is exempt.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that after turning the patient hemodynamics ++ unstable with bp down to 68/43 mmhg.Titrated vasopressors up, initiated fluid bolus, patient not responding to interventions.Writer noticed fluid on the ground and that 4 way stop cocks (2) had become disconnected from each other and middle twist lock connection and so vasopressors were not infusing.Attempted to reconnect, twist lock not functioning properly.Connections were manually held by rn while new "2 gang 3 way stop cock" was primed.Vasopressors were connected to new stop cock and hemodynamics were stabilized.Malfunctioning stop cocks compared to 2 newly opened 4 way stop cocks, the stop cocks that had been on patient do not lock securely at the twist lock/very easily released from each other.Unable to visualize crack on twist lock which resulted in critical hemodynamic instability.There was patient involvement and no patient harm.Two devices of the same part and lot number were involved on the same patient.

• Brand Name: MEDEX 4-WAY STOPCOCK
• Type of Device: STOPCOCK I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18809462
• MDR Text Key: 336804587
• Report Number: 1526863-2024-00010
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX9341L
• Device Lot Number: 4341417
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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
• Treatment: TITRATED VASOPRESSORS