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

Catalog Number 20127E

Device Problem Defective Component (2292)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite extension set was damaged the following information was received by the initial reporter with the following verbatim: iv tubing screw cap came off the line of lipid tubing was then contaminated and no longer able to be connected.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

It was reported by the customer iv tubing screw cap came off the line of lipid tubing was then contaminated and no longer able to be connected.No product or photo was returned by the customer.The customer complaint of component damage could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 20127e lot number 23129307 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20dec2023.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

No additional information was provided.Material#: 20127e, batch#: 23129307.It was reported by the customer iv tubing screw cap came off the line of lipid tubing was then contaminated and no longer able to be connected verbatim: rcc received a complaint via community.Pir attached.Iv tubing screw cap came off the line of lipid tubing was then contaminated and no longer able to be connected comments on (b)(6) 2024.1.Please confirm that batch number.(10)23129307.2.Please provide the address of the facility for us to ship the return label? (b)(6).3.Did the event directly, or indirectly involve a patient or user? unknown.4.Did the event involve an urgent/life threatening medical situation? no.5.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.No harm.

Event Description

No additional information was provided.Material#: 20127e batch#: 23129307 it was reported by the customer iv tubing screw cap came off the line of lipid tubing was then contaminated and no longer able to be connected rcc received a complaint via community.Pir attached.Iv tubing screw cap came off the line of lipid tubing was then contaminated and no longer able to be connected comments on 12/02/2024 1.Please confirm that batch number.(10)23129307 2.Please provide the address of the facility for us to ship the return label? (b)(6).3.Did the event directly, or indirectly involve a patient or user? unknown 4.Did the event involve an urgent/life threatening medical situation? no 5.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.No harm.

Manufacturer Narrative

It was reported by the customer iv tubing screw cap came off the line of lipid tubing was then contaminated and no longer able to be connected no product or photo was returned by the customer.The customer complaint of component damage could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 20127e lot number 23129307 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20dec2023.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.Ting our commitment to continuous quality improvement.

• Brand Name: BD ALARIS SMARTSITE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18803515
• MDR Text Key: 337530628
• Report Number: 9616066-2024-00330
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: 20127E
• Device Lot Number: 23129307
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1