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

Model Number 20350E

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

It was reported that the bd alaris smartsite low sorbing extension set experienced leaking around the iv filter site.The following information was provided by the initial reporter: this rn restarted the infusion and noted that there was leaking around the iv filter site.

Manufacturer Narrative

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

Manufacturer Narrative

H.6.Investigation summary: the customer reported leaking around the filter, and returned 17 20350e (b)(4).The used sample verifies the complaint and it leaked from the filter outlet, and with minimal effort the tubing separated off the filter.The filter outlet post broke off and stayed inside the tubing.The root cause is traced to excess solvent applied during assembly.The other 16 unused samples were all pressure tested for leaks in and around the filter, and none were found.Manufacturing has implemented fixtures to the solvent operation to aid in preventing failures of this type.Device history record review for model 20350e lot number 22029764 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd alaris smartsite low sorbing extension set experienced leaking around the iv filter site.The following information was provided by the initial reporter: this rn restarted the infusion and noted that there was leaking around the iv filter site.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING 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: 15331808
• MDR Text Key: 305373488
• Report Number: 9616066-2022-01261
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012264
• UDI-Public: 37613203012264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 20350E
• Device Catalogue Number: 20350E
• Device Lot Number: 22029764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• 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