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	MPX5301-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
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: we've received the following complaint form our clinical staff when using your mpx5301-c, please advise: we have recently found several iv adapters in sds that are leaking with suspected hole/tear in the line.Customer response: 1.Kindly provide the date of event.There were 3 different occurrences over the last week, the most recent being friday (b)(6) 2024.2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.There was no harm caused to the patients that we are aware of.All 3 adapters were found to be leaking once they were attached to a patient and iv fluids were infusing.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: mpx5301-c batch#: 24089052 it was reported by the customer that found several iv adapters in sds that are leaking with suspected hole/tear in the line.Verbatim: rcc received a complaint via email.Email(s) attached, we've received the following complaint form our clinical staff when using your mpx5301-c, please advise: we have recently found several iv adapters in sds that are leaking with suspected hole/tear in the line.Customer response: 1.Kindly provide the date of event.There were 3 different occurrences over the last week, the most recent being friday 9/6/2024.2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.There was no harm caused to the patients that we are aware of.All 3 adapters were found to be leaking once they were attached to a patient and iv fluids were infusing.3.We received only 2 pictures, if possible, could you please provide all pictures for investigation.I don't have any other pictures other than the ones that i sent you.4.Kindly confirm any physical sample if available for investigation? if yes, please provide the address of the facility for us to ship the return label? i do have the last adapter that we found to be leaking in my office.It's in a biohazard bag, as it was used on a patient.Let me know if you would like to pick up.5.Kindly provide the batch/lot number of the product.
Additional Manufacturer Narrative
It was reported by the customer that found several iv adapters are leaking with suspected hole/tear in the line.Two photos of the product packaging were received for quality evaluation.Photos of the product failure was not provided and therefore the customer complaint of component damage - leak could not be verified.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• 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: 20352270
• Report Number: 9616066-2024-01426
• Device Sequence Number: 18142532
• Product Code: FPA
• UDI-Device Identifier: 10885403237225
• UDI-Public: (01)10885403237225
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 12/19/2024

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: Other
• Device Catalogue Number: MPX5301-C
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 12/20/2024
• 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