MAUDE Adverse Event Report: BECTON DICKINSON 9 IN EXTENSION SET W/MAX Y; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MPX5302-C
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: mpx5302-c.Batch#: unknown.It was reported by customer that the side port of the extension set oozes blood while flushing.I take it that she is hooking a vacutainer to the side, proximal port and drawing blood and then flushing the distal port with saline.I don't know if this process is damaging the internal valve on the prox.Side port and causing the issue.Verbatim: rcc received a complaint via email.Email(s) attached.Good morning christine.One of our teammates has reported that the side port of the extension set oozes blood while flushing.I take it that she is hooking a vacutainer to the side, proximal port and drawing blood and then flushing the distal port with saline.I don't know if this process is damaging the internal valve on the prox.Side port and causing the issue.Do you have any guidance on this issue or can put me in contact with the rep who handles this device? thank you! md max plus ext set mpx5302-c.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
The customer reported leakage from the port, and returned videos of the issue.The videos verify leaking from the blue piston on the y-site of mpx5302-c.The physical sample was unable to be returned, and no device investigation was able to be performed.A device history record review could not be performed on material mpx5302-c because the lot number is unknown.
Event or Problem Description
No additional info.

• Brand Name: 9 IN EXTENSION SET W/MAX Y
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 19198335
• Report Number: 9616066-2024-00645
• Device Sequence Number: 20743180
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: (01)10885403237232(11)240202(17)270202(10)24029115
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (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): 10/23/2024

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: MPX5302-C
• Device Lot Number: 24029115
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown