MAUDE Adverse Event Report: BECTON DICKINSON EXT 8 - MZ5313; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ5313
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# mz5313 batch# unknown it was reported by customer that the y-set broke off in half.Verbatim: "today we used the new i.V.Y -set on a trauma pt.When we went to ct, during the contrast infusion, the y-set broke off in half as seen in the pictures.I experienced it once and the ct tech.(b)(6) had seen it 2 times.It delayed us from doing the ct.We had to careful replace the y- set with a single iv.Connection.".
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.H3 other text : see h10 manufacture narrative,.
Additional Manufacturer Narrative
It was reported that the y-site broke in half.One sample model mz5313, lot 24019045 was returned for investigation.The set was examined for defects and abnormalities.The distal tubing was separated from the y-site no other defects or abnormalities were observed.Visual inspection under the microscope showed no signs of solvent.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the possible root cause is using an incorrect solvent application method/omission by the assembler.A quality alert was created on may 23, 2024 to communicate the failure and reinforce the correct solvent application method and avoid the lack of solvent between the components.A device history record review for model mz5313 lot number 24019045 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04jan2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional info.

• Brand Name: EXT 8 - MZ5313
• 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: 19300383
• Report Number: 9616066-2024-00711
• Device Sequence Number: 20297212
• Product Code: FPA
• UDI-Device Identifier: 10885403471261
• UDI-Public: (01)10885403471261
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 06/19/2024

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: MZ5313
• Device Lot Number: 24019045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown