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

Model Number 10014881

Device Problem Break (1069)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd alaris smartsite low sorbing secondary set the tubing broke and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: another tubing breakage happened.

Event Description

It was reported while using bd alaris smartsite low sorbing secondary set the tubing broke and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: another tubing breakage happened.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 05-may-2023.H6: investigation summary the customer reported the tubing broke, and returned one used sample.The sample had separated at the drip chamber, and the complaint is verified.The root cause was found to be insufficient solvent at the tubing connection.Manufacturing has implemented a funded project and team to address the issue.They are working to mitigate the risk of further failures of this type on several material numbers.Device history record review for model 10014881 lot number 22109185 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING SECONDARY 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 ; 8448235433
• MDR Report Key: 16433508
• MDR Text Key: 310245786
• Report Number: 9616066-2023-00256
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403221932
• UDI-Public: (01)50885403221932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• 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: 05/22/2023

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: Health Professional
• Device Model Number: 10014881
• Device Catalogue Number: 10014881
• Device Lot Number: 22109185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1