MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD STOPCOCK(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	M4018
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxguard stopcock(s) was leaking.The following information was received by the initial reporter with the following verbatim.Rn was infusing propofol through stopcock, port started leaking propofol.Rn states stopcock was opened correctly.Unsure how long propofol was infusing through tubing and stopcock before this occurred.Additional information received on (b)(6).Two incidences were reported of nursing infusing propofol through the tri smallbore tubing extension set (ref # (b)(4)): 1.Exact dates were the weekend of (b)(6).2.Yes, when the nurse detached the extension set and flushed the tubing there was a notable whole in the tubing where fluid was infusing out of.3.Yes, the patient started to wake up and almost self extubated.
Additional Manufacturer Narrative
It was reported that the port started leaking.One videos shows the leakage from the port.Due to no sample being received a root cause could not be determined.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
Material # m4018, batch # unknown.It was reported by customer that they were infusing propofol through stopcock, port started leaking propofol.Verbatim: m4018.Rn was infusing propofol through stopcock, port started leaking propofol.Rn states stopcock was opened correctly.Unsure how long propofol was infusing through tubing and stopcock before this occurred.Additional information received on 05nov.Two incidences were reported of nursing infusing propofol through the tri smallbore tubing extension set (ref # 20338e): 1.Exact dates were the weekend of october 24th-26th.2.Yes, when the nurse detached the extension set and flushed the tubing there was a notable whole in the tubing where fluid was infusing out of 3.Yes, the patient started to wake up and almost self extubated.4.No.5.There is a video that was included in the original rl.6.Unable to verify lot number at this time.

• Brand Name: BD MAXGUARD STOPCOCK(S)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20760228
• Report Number: 9616066-2024-01726
• Device Sequence Number: 13082079
• Product Code: FPA
• UDI-Device Identifier: 10885403235740
• UDI-Public: (01)10885403235740
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: Other
• Device Catalogue Number: M4018
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown