MAUDE Adverse Event Report: BECTON DICKINSON MAXPLUS POSITIVE PRESSURE CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MP1000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The connector leaks at the interface when connected to the infusion set.A claim is required, a complaint response letter is required, and a complaint acceptance letter is required.One defective product can be returned.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A mp1000 china product was not available for investigation for the (b)(4); however, the customer confirmed that the complaint sample was from lot 23085470.The feedback provided by the customer states that, "the connector leaks at the interface when connected to the infusion set." further information from the customer has stated that the leakage was noticed within half an hour of the ordinary liquid medicine infusion when the connector was connected with wego precision infusion set.Additionally, customer has confirmed that sample was sterilized by using alcohol pads.Moreover, customer has confirmed that the components are not in contact with the needle before reusing and there was no visible damage on the product.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 23085470 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the product mp1000 china in the past 12 months.

• Brand Name: MAXPLUS POSITIVE PRESSURE CONNECTOR
• 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: 20873770
• Report Number: 9616066-2024-01918
• Device Sequence Number: 12935191
• Product Code: FPA
• UDI-Device Identifier: 10885403232985
• UDI-Public: (01)10885403232985
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: MP1000
• Device Lot Number: 23085470
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/07/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown