MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MPX5300-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxplus pressure rated extension set with needleless connector and y-site was damaged the following information was received by the initial reporter with the following verbatim: the white part of the smartsite injection port is cracked and it leaks when fluid is administered.It's not easily visible and requires some prssure to leak.See pictures and videos attached.Inicdent occured in the icu to administer fentanyl.It,s the second similar incident in the icu.The first one occured in february (pir3077939) the lot number is not available and it was not available for the firt pir either.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
It was reported that the white part of the smartsite injection port is cracked and it leaks when fluid is administered.One sample model mpx5300-c, lot 23129297 was returned for investigation.The set was examined for defects and abnormalities.A crack was seen on the y-sites luer activated device.No defects or abnormalities were observed.The luer activated device was connected to a 10 ml bd syringe filled with water and flushed.Leak was observed coming from the crack on the y-site.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the failure mode could not be confirmed to be related to the tj manufacturing process.A device history record review for model mpx5300-c lot number 23129297 was performed.The search showed that a total of 11603 units in 1 lot number was built on 19dec2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• 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: 19402570
• Report Number: 9616066-2024-00800
• Device Sequence Number: 7754041
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: (01)10885403237218
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: MPX5300-C
• Device Lot Number: 23129297
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown