MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX 3-WAY SMALL BODY STOPCOCK WITH SWIVEL MALE LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MX5311L
Medical Device Problem Codes	Backflow (1064); Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that twice the threads broke in the luer lock valve; which caused leaking of the medicine given to the patient.The other time, the luer lock valve caused back flow into the patients iv.The stop cocks have been pulled from the shelf in this area and given to the central supply team.There was patient involvement.Item broke while pushing meds and no patient harm.Exact weight of the patient was 100.24 kg.
Additional Manufacturer Narrative
H3 - other: device has not been returned to date.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.
Additional Manufacturer Narrative
No devices were returned, and no photos were provided for evaluation and testing.The dhr for the final assembly as well as all the molded components that go into the assembly were reviewed for nonconformances brought up during their manufacturing relating to the defect described.No ncmrs written related to the defect described.The complaint cannot be confirmed.Customer complaint history was reviewed for the past two years, and no other complaints were identified with the described defect.No further action will be taken at this time.

• Brand Name: MEDEX 3-WAY SMALL BODY STOPCOCK WITH SWIVEL MALE LUER LOCK
• Common Device Name: 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: 18607888
• Report Number: 1526863-2024-00005
• Device Sequence Number: 13020085
• Product Code: FMG
• UDI-Device Identifier: 10351688506795
• UDI-Public: (01)10351688506795(17)260823(10)4428040
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2026
• Device Catalogue Number: MX5311L
• Device Lot Number: 4428040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 100 KG