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

Catalog Number	20128E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was separating the following information was received by the initial reporter with the following verbatim: it was reported by customer that filter tubing coming apart.
Additional Manufacturer Narrative
The customer reported tubing came apart, and the customer returned 8 samples, there were also two labels for material 20128e, lot 24059101.The sets were visually examined, and the complaint was verified.There were 8 samples total, 6 with separation at tubing/female luer, and 2 without separation.The separated tubings were examined under a microscope, and insufficient solvent was found.The manufacturing plant found the root cause for the separation at female luer to be related to the solvent application process.The process was done incorrectly by the assembler.The material 20128e is under process of obsolescence, and during this time, the production of the sku is not scheduled.Since the sku is not expected to be manufactured or released, no actions to the assembly were necessary.If the material is to be manufactured, there will be a standard work instruction reinforcement with the production personnel.Device history record review for model 20128e lot number 24059101 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07may2024.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 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: 19927239
• Report Number: 9616066-2024-01095
• Device Sequence Number: 2847357
• Product Code: FPA
• UDI-Device Identifier: 07613203011839
• UDI-Public: (01)07613203011839
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/12/2024

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 Catalogue Number: 20128E
• Device Lot Number: 24059101
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown