MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero multi-fuse pressure rated extension set with needleless connector was leaking.The following information was received by the initial reporter with the following verbatim: it was reported by customer that these ends always leave a bubble of fluid on the end, and they had blood clot with these connectors.
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.
Additional Manufacturer Narrative
It was reported by customer that these ends always leave a bubble of fluid on the end, and they had blood clot with these connectors.Two photos of the product were submitted for quality evaluation.Investigation of the photos show the product still inside the packaging and a product with appears to have blood remaining in the tubing, however, none of the photos provided indicated leakage.The customer complaint of leakage could not be verified.A root cause for the reported failure could not be determined because the photos did not depict the failure reported and no physical sample was provided.A device history record review for model mz5301 lot number 24049080 was performed.The search showed that a total of 32,003 units in 1 lot number was built on 02apr2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by customer that these ends always leave a bubble of fluid on the end, and they had blood clot with these connectors.Two photos of the product were submitted for quality evaluation.Investigation of the photos show the product still inside the packaging and a product with appears to have blood remaining in the tubing, however, none of the photos provided indicated leakage.The customer complaint of leakage could not be verified.A root cause for the reported failure could not be determined because the photos did not depict the failure reported and no physical sample was provided.A device history record review for model: mz5301, lot number: 24049080 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02apr2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material#: mz5301, batch#: 24049080.It was reported by customer that these ends always leave a bubble of fluid on the end, and they had blood clot with these connectors.Rcc received a complaint via email.We have had concerns brought to us regarding these connectors and the connectors that have the same ends but no extension tubing.I will try to include some of the concerns in this email.We are wondering if there is an alternative product we could try? we have a concern with these.Today we had our radiation safety meeting and it was brought to our attention by nuc.Medicine that these ends always leave a bubble of fluid on the end.In nm this is radioactive and can lead to contamination of the area.We can see an increase in dose to our technologist (they wear a radiation badge on their finger to monitor the dose from handling the syringes)-we are thinking some of that is due to the drip of liquid that falls onto their gloves.I also want to include the blood clot we had with these connectors.These connectors have been brought up by my staff as a concern on 3cc.They have stated that the tubing diameter is small and it causes difficulties when trying to administer some push medications.The pressure during power injections seems higher than normal and there is always fluid remaining on the end of the hub.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH 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: 20295974
• Report Number: 9616066-2024-01365
• Device Sequence Number: 7171194
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: (01)10885403230547(11)240402(17)270402(10)24049080
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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,Followup
• Report Date (Section B): 01/21/2025

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: MZ5301
• Device Lot Number: 24049080
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 01/21/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 01/15/2025; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown