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

Catalog Number	MPX5302-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: mpx5302-c batch#: unknown it was reported by the customer that item imempx5302c is leaking.Verbatim: rcc received a complaint via email.Email(s) attached item: mpx5302-c quantity affected:2ea serial/lot number:unk po : 4517509137 are any samples available for return? yes reported issue: customer xxxx emailed stating that item imempx5302c is leaking.
Additional Manufacturer Narrative
Initial mdr submission with device evaluation.He customer reported leakage, and returned one sample of material mpx5302-c, lot 24059222.Upon initial visual examination, the set had no defects or abnormalities.The set was then tested at all connections with a 10 ml bd syringe, but no leakage was found.All connections were plugged/closed to create pressure.The complaint could not be verified.The root cause could not be found without a verified failure.Device history record review for model mpx5302-c lot number 24059222 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09may2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• 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): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19940754
• Report Number: 9616066-2024-01110
• Device Sequence Number: 4953482
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: (01)10885403237232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/15/2024

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: 24059222
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/08/2024
• 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