MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP5314-C

Device Problem Component Missing (2306)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported that the bd maxplus pressure rated extension set with removable needleless connector was missing component.The following information was provided by the initial reporter: mtm2 found extension set missing one of the ends during production.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D4.Medical device lot #: the customer reported, lot #: 22079077, but this was not found to be associated with the reported material number.

Event Description

It was reported that the bd maxplus pressure rated extension set with removable needleless connector was missing component.The following information was provided by the initial reporter: mtm2 found extension set missing one of the ends during production.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 22-jun-2023.H.6.Investigation summary: two hundred six samples of the mp5314-c tubing and 155 maxplus connectors were received for quality investigation.Two samples of the 206 samples were seen to be missing the male luer connector or both the male and female luer connectors.The customer complaint of misassembly was confirmed by visual inspection.Further examination of the two samples shows that there is an absence of solvent at the end of each tubing.The additional tubing samples submitted did not have the maxplus connectors connected to the assemblies.The tubing samples have male and female connectors on securely connected each end.The 155 samples of the maxplus connectors were not assembled on the tubing and provided in a separate plastic bag from the tubing assemblies.Connecting the maxplus connectors to the extension set tubing and pushing water through the full assembly using a water filled syringe, did not indicate any flow issues, connection issues or air-in-line issues.After investigation, the main contributor of misassembly/missing of the female and male luer could be related to not following the assembly instructions and incorrect segregation of suspect material by the assembler.A quality alert has will be generated to reinforce the correct assembly of the model and the correct segregation of the suspect material to avoid this issue in future production.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17081232
• MDR Text Key: 317139131
• Report Number: 9616066-2023-01129
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236723
• UDI-Public: (01)10885403236723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083472
• 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: 06/22/2023

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: MP5314-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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