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

Catalog Number	20519E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was separated the following information was received by the initial reporter with the following verbatim we have been having issues with our manifold extension again.It is coming undone at the connection that i have circled.That connection is together when we open the package but if we do not tighten it, some will come apart and either leak or fall off onto the floor or desk, then we have to get all new tubing.This instance happened today and another incidence about 1 mo.Ago.Please open a new complaint for this and confirm the material number with (b)(4).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.Material#: 20519e batch number#: 23089095 it was reported by customer that they are having issues with manifold extension again.It is coming undone at the connection that i have circled.That connection is together when opening the package but if do not tighten it, some will come apart and either leak or fall off onto the floor or desk, then we have to get all new tubing.This instance happened today and another incidence about 1 mo.Ago.Rcc received a complaint via email.Email(s) attached.Please see the following complaint received from (b)(6).Material and lot number is unknown but is most likely mp5312-c or (infusion disposable) we have been having issues with our manifold extension again.It is coming undone at the connection that i have circled.That connection is together when we open the package but if we do not tighten it, some will come apart and either leak or fall off onto the floor or desk, then we have to get all new tubing.This instance happened today and another incidence about 1 mo.Ago.Please open a new complaint for this and confirm the material number with (b)(6).Customer reply: date was day of email only material information was sent in picture no negative outcome this time, contamination prior to patient use no sample available photo previously shared but will resend.
Additional Manufacturer Narrative
It was reported by customer that they are having issues with manifold extension again.It is coming undone at the connection that i have circled.That connection is together when opening the package but if do not tighten it, some will come apart and either leak or fall off onto the floor or desk, then we have to get all new tubing.One photo was submitted for material 20519e.Evaluation of the photo submitted shows that the female luer that is supposed to be connected to the male luer connector of the connector manifold, had separated.The customer complaint that the infusion set is become separated when in use was verified.The investigation was forwarded to manufacturing for further evaluation.After the investigation was conducted, the possible root cause is that the assembly was not completed during the addition of the female luer end of the manifold, by the assembler.A quality alert was generated to reinforce the correct assembly between the female luer connection and the manifold.An adjustment was made to screw the connection until stop, and thus preventing a weak union/gap between components.A device history record review for model 20519e lot number 23089095 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04aug2023.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.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18675788
• Report Number: 9616066-2024-00213
• Device Sequence Number: 17690968
• Product Code: FPA
• UDI-Device Identifier: 10885403234941
• UDI-Public: (01)10885403234941
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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
• Operator of Device: Other
• Device Expiration Date: 08/04/2026
• Device Catalogue Number: 20519E
• Device Lot Number: 23089095
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown