MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXPLUS NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP1000 CHINA
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A mp1000 china product was not available for investigation; however, the customer confirmed that the complaint sample was from lot 23085470.The feedback provided by the customer states that, "found to be leaking fluid during the course of an iv infusion, and it was viewed to be leaking at the needleless connector." no further information was available to assist the investigation in this instance.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.
Event or Problem Description
It was reported that bd maxplus needleless connector was leaking the following information was received by the initial reporter with the following verbatim the patient was admitted to the hospital with osteoarthritis of the knee and was found to be leaking fluid during the course of an iv infusion given at 18:00 on (b)(6) 2024, and was viewed to be leaking at the needleless connector, and was given a new needleless connector with no leakage.

• Brand Name: BD MAXPLUS NEEDLELESS CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• 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: 20511452
• Report Number: 9616066-2024-01527
• Device Sequence Number: 7026642
• Product Code: FPA
• UDI-Device Identifier: 10885403232985
• UDI-Public: (01)10885403232985(10)23085470
• 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: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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: Other
• Device Catalogue Number: MP1000 CHINA
• Device Lot Number: 23085470
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/22/2024
• 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