MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE ALARIS CHECK VALVE 4 NEEDLE GRAVITY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	C42014E-07
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd smartsite alaris check valve 4 needle gravity set the tubing clamp was damaged.There was no report of patient impact.The following information was provided by the initial reporter: when tubing was opened it was noted that the clamp was not placed correctly on tubing making it not functional.Xxx has product saved at the site for investigation, if needed.Response received 25 sep 2023 : how many occurrences of the defective set(s)? only 1 set at this time.Kindly confirm whether or not there was patient involvement.Defective clamp was found before it reached the patient.Addt response received 26 sep 2023: the lot number is (10)23079266.Product will be going out today.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample of item#: c42014e-07, lot #: 23079266 was submitted for quality evaluation.The customer complaint of misassembly was verified by visual inspection.Investigation of the sample shows that the tubing of the extension set was inserted incorrectly in the roller clamp, and does not go through the entire roller clamp.The tubing is inserted into one side of the roller clamp body, but exits the roller clamp body through the opening in the clamp body meant for the movement of the roller.There were no additional issues with the sample.A device history record review for model c42014e-07 lot number 23079266 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue is a misassembly during the assembly of the infusion set.Further investigation was conducted at the manufacturing facility and it was determined that not using the assembly fixture caused the roller clamp to not be installed correctly.A work order has been established to carry out an inspection of the assembly fixtures.Additionally, a quality alert was created and communicated to the production personnel to reinforce the escalation process and notify staff when a fixture is damaged.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 or Problem Description
No additional information.Material #: c42014e-07, batch #: 23079266.It was reported by customer that when tubing was opened it was noted that the clamp was not placed correctly on tubing making it not functional.Verbatim: rcc received a complaint via email.Email(s) attached.When tubing was opened it was noted that the clamp was not placed correctly on tubing making it not functional.Xxx has product saved at the site for investigation, if needed.Response received 25 sep 2023.How many occurrences of the defective set(s)? only 1 set at this time.Kindly confirm whether or not there was patient involvement.Defective clamp was found before it reached the patient.Addt response received 26 sep 2023.The lot number is (10)23079266.Product will be going out today.

• Brand Name: BD SMARTSITE ALARIS CHECK VALVE 4 NEEDLE GRAVITY SET
• Common Device Name: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17861251
• Report Number: 9616066-2023-01995
• Device Sequence Number: 12195038
• Product Code: FPA
• UDI-Device Identifier: 07613203020756
• UDI-Public: (01)07613203020756
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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
• Operator of Device: Other
• Device Expiration Date: 07/27/2026
• Device Catalogue Number: C42014E-07
• Device Lot Number: 23079266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown