MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. PRESSURE RATED EXT SET, IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ5303
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported separation.Description: it was reported that "when flushing the valve with nacl, there was a spontaneous misalignment of the valve between the tubing and the valve".
Additional Manufacturer Narrative
Investigation result: one mz5303 sample was received without packaging for investigation.No residual fluid was present and no connecting product was returned with the sample.The customer reported that the affected sample was from lot 25079108 and that "when flushing the valve with nacl, there was a spontaneous misalignment of the valve between the tubing and the valve".Visual inspection of the returned sample confirmed the customer's experience; the maxzero was separated from the female luer.The details of this feedback were forwarded to the manufacturing site for investigation.Following a review of the manufacturing process, their analysis confirmed that the separation is most likely to have been caused by an insufficient amount of solvent having been applied to the tubing joint during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 25079108 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback and retrained to ensure that they are following the correct assembly process.Please note, since the manufacture of the affected product, the assembly of this product has moved to an alternative manufacturing site.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the mz5303 product over the past 12 months.
Event or Problem Description
The sample available for analysis was used, then disinfected with ddn9 pre-disinfection for 15 minutes.There is no visible damage.The patient was not injured.

• Brand Name: PRESSURE RATED EXT SET, IV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24223357
• Report Number: 9616066-2026-00181
• Device Sequence Number: 8392733
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: (01)10885403230561(11)250730(17)280729(10)25079108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: Health Professional
• Device Catalogue Number: MZ5303
• Device Lot Number: 25079108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown