MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ULTRA(TM) 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK 50/CA; STOPCOCK, I.V. SET

Catalog Number	MX2341L
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the stopcocks on 1 lumen of patient's picc line came disconnected.Upon discovery, promptly notified picc registered nurse for troubleshooting.The outcome of the event was resolved, a heparin flush through the picc line was given and stopcocks were removed.There was no patient harm/adverse event reported.
Event or Problem Description
Gcm received and reviewed email via service cloud on 5-aug-2024 from (b)(6), regarding an ultra(tm) 4-way stopcock w/swivel male luer lock 50/ca with item number mx2341l lot number 4470067.It was stated that the stopcocks on 1 lumen of patient's picc line came disconnected.Upon discovery, promptly notified picc registered nurse and troubleshooted.It is unknown if the device is available for investigation.Sample photos were provided by the customer.There was patient involvement, and unknown patient harm/adverse event reported.(b)(6) 2024.Update: gcm received an email on 9-aug-2024 from (b)(6) informing that the product was thrown out and is not available.The event occurred on (b)(6) 2024 during infusion in the nicu.The outcome of the event was resolved, a heparin flush through the picc line was given and stopcocks were removed.There was no patient harm/adverse event reported.(b)(6) 2024.

• Brand Name: ULTRA(TM) 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK 50/CA
• 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 ; 600 n. field dr.; lake forest, MN 55442 ; 2247062300
• MDR Report Key: 20070965
• Report Number: 1526863-2024-00081
• Device Sequence Number: 3075395
• Product Code: FMG
• UDI-Device Identifier: 10351688508324
• UDI-Public: (01)10351688508324(17)270307(10)4470067
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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 Catalogue Number: MX2341L
• Device Lot Number: 4470067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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 Sex: Unknown