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

Catalog Number MPX5302-C

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: 9 IN EXTENSION SET W/MAX Y
• Type of Device: 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
• MDR Text Key: 341681815
• Report Number: 9616066-2024-00645
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: (01)10885403237232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MPX5302-C
• Device Lot Number: 24029115
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1