MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD MAXZERO PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5309
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero pressure rated extension set had connection issues.The following information was provided by the initial reporter: the maxzero j loop extension sets are blowing apart particularly with cta work.The ct techs have reported this to me this week.I am told this has been occurring for approx.2 months.They were hesitate at first of reporting thinking it was a one off or an isolated incident.It is occurring with patients from the er but also the op exams when our ct staff is starting those ivs.They assure me they are connecting correctly and screwing it down tightly.It seems this may be a real problem.This is causing some delays in testing as they are having to redose the patient with iv contrast along with a sticky mess to clean up on the patient as well as the exam room.We have reverted back to saline locks directly to the hub of the iv catheter and not using the j loops for now.Additional information received from the customer: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No serious injury has occurred although the adverse event would be that the patients are having to given iodinated contrast twice.At the time of the initial administration of contrast, the j loop blows off.The patient does receive some contrast but there is no way of knowing how much as the remainder is sprayed throughout the room.Some patients do not have great kidney function and may be borderline to receive iodinated contrast initially and redosing is not always ideal but needed for the completion of the test.
Additional Manufacturer Narrative
Device evaluation: no product or photo was returned by the customer.The customer complaint of connection issues could not be verified due to the product not being returned for failure investigation.A device history record review for material# mz5309 and lot# 25059087 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29may2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.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: BD MAXZERO PRESSURE RATED EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23386586
• Report Number: 9616066-2025-03262
• Device Sequence Number: 11993819
• Product Code: FPA
• UDI-Device Identifier: 10885403242083
• UDI-Public: (01)10885403242083(11)250529(17)280528(10)25059087
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2025

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: Other
• Device Catalogue Number: MZ5309
• Device Lot Number: 25059087
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown