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

Catalog Number MZ5303

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that bd maxzero pressure rated ext set, iv connector is disconnecting at the connection the following information was provided by the initial reporter, translated from japanese to english: this is a complaint about infusion set comes off from the female side (mixing part).According to the customer report when the infusion set for the pump is connected to the female side (mixing part) for the purpose of administering solugen during lvlg therapy, the infusion set for the pump is disconnected from the female side (mixing part).

Manufacturer Narrative

E.Address too long for box: (b)(6).

Manufacturer Narrative

Investigation results: one mz5303 sample was received for investigation of pr 9458580; no packaging was received with the sample.Residual fluid was present throughout the line, and blood was present in the male luer; no connecting product was provided to aid the investigation.The customer reported that the set disconnected during use from the female luer adaptor (fla) of the maxzero.Functional testing was performed by connecting various products from bd stock to the mz5303; in each instance the connection was found to be secure, and no fluid leakage or air ingress was observed when the samples were flushed.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects or quality deviation that could have contributed to the customer¿s experience.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mz5303 set in the past 12 months.

Event Description

No additional information.

• Brand Name: BD MAXZERO PRESSURE RATED EXT SET, IV CONNECTOR
• Type of Device: 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: 18533462
• MDR Text Key: 333213819
• Report Number: 9616066-2024-00023
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: (01)10885403230561
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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
• Device Operator: Other
• Device Catalogue Number: MZ5303
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1