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

Catalog Number 47233E

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 alaris¿ smartsite¿ gravity set tubing was "stiff" and didn't connect well during use.The following information was provided by the initial reporter: "the tubing is now more stiff and not connecting well".

Manufacturer Narrative

H6: investigation summary: two samples were received and tested by our quality team.There was a drip chamber without attached tubing as well as a 447233e full set with the complaint of connection issues and stiff tubing.The intact tubing was tested and there were no issues or abnormalities after thorough examination.No root cause is available and it is assumed that this was the "stiff tubing" set.A device history record review for model 47233e lot number 22099386 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.

Event Description

It was reported that the bd alaris¿ smartsite¿ gravity set tubing was "stiff" and didn't connect well during use.The following information was provided by the initial reporter: "the tubing is now more stiff and not connecting well".

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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: 16390332
• MDR Text Key: 309743221
• Report Number: 9616066-2023-00229
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235443
• UDI-Public: 10885403235443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47233E
• Device Lot Number: 22099386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2022
• 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