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

Catalog Number MP2002C-0006

Device Problem Component Missing (2306)

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

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd maxguard¿ multi-fuse extension set with needleless connector was missing the maxplus valve.The following information was provided by the initial reporter: "connection problem between the maxplus luer tip and the luer lock of the infusion line with the same lot number : one piece didn't contain maxplus valve and the other one, it was difficult to screw the luer-lock male of the iv set with maxplus valve.".

Manufacturer Narrative

H.6.Investigation summary: a mp2002c-0006 sample was not available for investigation; however the customer indicated the complaint sample was from lot 22049397.The feedback provided by the customer suggests that the maxplus had not been correctly assembled onto the extension set.As part of the feedback the customer provided a photograph; analysis of the photograph confirmed the customer's experience as the maxplus had separated from the extension set.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22049397 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mp2002c-0006 product.

Event Description

It was reported that the bd maxguard¿ multi-fuse extension set with needleless connector was missing the maxplus valve.The following information was provided by the initial reporter: "connection problem between the maxplus luer tip and the luer lock of the infusion line with the same lot number : one piece didn't contain maxplus valve and the other one, it was difficiult to screw the luer-lock male of the iv set with maxplus valve.".

• Brand Name: BD MAXGUARD¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16959486
• MDR Text Key: 315860029
• Report Number: 9616066-2023-00959
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP2002C-0006
• Device Lot Number: 22049397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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