MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD STOPCOCK 4 WAY ROTARY LOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	M4018
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd maxguard stopcock 4 way rotary lock leakage and flow issues occurred.The following information was provided by the initial reporter: upon further inspection this rn noticed the bed was wet.The specific buff cap that the lipids were hooked up to was found to be wet and dripping and no lipids appeared to be moving further than that buff cap.The pt's tpn/lipids were hung at 1700, so patient was without fluids for approximately 4 hours.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: 1 sample (model # m4018) was received for investigation.Prior to functional testing the sample was visually examined for defects and abnormalities.No defects or abnormalities were observed.The sample was attached to a bd extension set (model # mp5301-c).The setup was flushed by using 10 ml bd syringe filled with 85% glycerin / 15% water solution.The sample flushed successfully with no leakage or fluid blockage was observed.The customer complaint that there was fluid blockage and leakage was not replicated.A device history record review for model m4018 and lot number 22099388 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.The root cause of this complaint could not be definitively determined because the issue could not be replicated.
Event or Problem Description
It was reported while using bd maxguard stopcock 4 way rotary lock leakage and flow issues occurred.The following information was provided by the initial reporter: upon further inspection this rn noticed the bed was wet.The specific buff cap that the lipids were hooked up to was found to be wet and dripping and no lipids appeared to be moving further than that buff cap.The pt's tpn/lipids were hung at 1700, so patient was without fluids for approximately 4 hours.

• Brand Name: BD MAXGUARD STOPCOCK 4 WAY ROTARY LOCK
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16031086
• Report Number: 9616066-2022-02031
• Device Sequence Number: 7224139
• Product Code: FPA
• UDI-Device Identifier: 10885403235740
• UDI-Public: 10885403235740
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 22099388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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