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  

Manufacturer Narrative

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

It was reported that bd maxzero pressure rated ext set, iv connector disconnected at a connection.The following information was provided by the initial reporter, translated from japanese to english: the infusion set comes off from the female side (mixed injection part).When customer connected the pump infusion set to the female side (mixed injection part) for the purpose of administering solugen during lvlg therapy, the pump infusion set became disconnected.

Manufacturer Narrative

Investigation results: one mz5303 sample was received without packaging for investigation.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; no information regarding the lot was reported.Functional testing was performed using connecting products from bd stock; in each instance the connection was found to be secure, and no fluid leakage or air ingress was observed when the samples were flushed with a bd 50ml plastipak syringe.The details of this feedback were forwarded to the manufacturing site for investigation.A lot number was not provided as part of the investigation; however a review of the laser id (b)(6) from the maxzero component confirmed a possible lot number to be either 23039151 or 23039152.A review of the production records for listed did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.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.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.

• 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: 18533867
• MDR Text Key: 333269518
• Report Number: 9616066-2024-00026
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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
• Device Lot Number: UNKNOWN
• 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: 02/14/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1