MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZX5306

Device Problem Product Quality Problem (1506)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported while using a bd maxzero¿ extension set the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by customer that " the iv catheter side was down on the extension tubing was unable to use it to connect to the iv catheter hub.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 26-sep-2022.H6: investigation summary two samples were submitted of material number mzx5306, lot number 22029806.The customer complaint of adaptor connector / damaged could not be verified.Inspection of the samples submitted did not show any indication of damage to the components of the assembly.In addition to the inspection, comparison to the component design drawings and the build of materials for the full assembly verified that the construction of the extension set was correct.The samples were primed and connected to a syringe filled with water to the maxzero connector of the extension set.The male luer connection was also capped in order to keep pressure in the extension set assembly.Steady pressure was applied to the syringe in order to induce leakage from the extension set.There were no indications of leakage, air-in-line, or occlusions noticed at any point during the testing of the extension set.Additionally, the connection was manipulated to see if the cap on the male luer connector or the connection to the maxzero connector would loosen.There were no signs of loosing of the connection.The male luer collar does have the ability to spin and can be moved away from the solid inner plastic tubing if the user aligns the groove of the design correctly.There is not a defect in the component.A device history record review for model mzx5306 lot number 22029806 was performed.A root cause could not be determined because the failure reported could not be reproduced and verified.Further investigation into the luer indicates that there are two approved styles of luers for this assembly.One of the approved constructions allows for the securement collar to slide down onto the connected tubing, the other approved construction restricts the movement of the securement collar throughout the tubing assembly, and therefore is not considered a defect or damage.

Event Description

It was reported while using a bd maxzero¿ extension set the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by customer that " the iv catheter side was down on the extension tubing was unable to use it to connect to the iv catheter hub.".

• Brand Name: BD MAXZERO¿ EXTENSION SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15480290
• MDR Text Key: 306409816
• Report Number: 9616066-2022-01409
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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: MZX5306
• Device Lot Number: 22029806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1