MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E CHINA

Device Problem Contamination (1120)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

A 2000e china product was not available for investigation; however, the customer indicated the complaint sample was from lot 22045847.The feedback provided by the customer suggests contamination was visible on the smartsite component.As part of the investigation the customer provided photographs; analysis of the photographs confirmed the customer's experience as a brown contaminant was detected on the white female luer adaptor (fla) of the smartsite.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22045847 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.Please note, the 2000e china sets are manufactured in an iso standard clean room which is under a positive pressure to push dust and particles out of the manufacturing area.The workers wear protective clothes including headwear and the clean room area is regularly cleaned according to a cleaning plan.In addition to this, final products are subjected to visual inspections for such issues.The most likely root cause is that a member of the clean room staff did not correctly follow the clean room procedures due to human error.

Event Description

It was reported while using bd smartsite¿ needle-free connector, priming volume 0.11 ml there were stains.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: when the nurse checked the infusion connector, she found stains on the connector and replaced it with a new needle-free airtight infusion connector.

• Brand Name: BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML
• 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: 16427769
• MDR Text Key: 310362777
• Report Number: 9616066-2023-00250
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403498227
• UDI-Public: (01)20885403498227
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

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: Health Professional
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: 22045847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2023
• Initial Date FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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