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

Catalog Number	MZ9277
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set with needleless connector(s) was occluded.The following information was received by the initial reporter with the following verbatim liquids are very difficult to spray through the tubing.When did the incident occur? during use.In the emergency department, in the its and in endoscopy, there have been an increasing number of problems, regardless of which fluid was administered.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
D4.Medical device lot #: 22049334, d4.Medical device lot #: 22049335, d4.Medical device lot #: 22049314.One hundred and sixty-three mz9277 samples were received in sealed packaging for investigation of (b)(4) (79x lot 22049314, 49x lot 22049334, and 35x lot 22049335), in which the customer has stated: "liquids are very difficult to spray through the tubing." ten samples from each received lot were picked at random and subjected to functional testing using a 5ml bd luer slip syringe and a 50ml bd plastipak luer lock syringe from stock; no occlusion or flow restriction was observed throughout testing of the returned samples with either syringe.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22049314, 22049334, and 22049335 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, this is a microbore tubing set, the smaller bore of the tubing means that a higher resistance is placed upon the fluid during infusion, especially at a higher infusion rate.This can translate into an increased force being required to manually prime or inject into the infusion line.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz9277 product in the past 12 months.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: 19618427
• Report Number: 9616066-2024-00941
• Device Sequence Number: 6948384
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: (01)10885403240799
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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 Expiration Date: 04/26/2025
• Device Catalogue Number: MZ9277
• Device Lot Number: SEE H.10
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown