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

Catalog Number	30204E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set was found to be discolored.The following information was provided by the initial reporter: discoloration of product.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set was found to be discolored.The following information was provided by the initial reporter: discoloration of product.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 08-feb-2023.H6: investigation summary an unopened sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The female luer was discolored and darker than the rest of the set.A device history record review for model 30204e lot number 22109399 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect, and an investigation was performed where possible root causes were determined.A potential root cause for this defect was determined as an issue at the supplier.The supplier was notified of this defect.An investigation could not be performed as the set had already been sterilized.Another potential root cause of this discoloration is related to the sterilization procedure which iv sets undergo to help ensure product sterility.These iv sets are sterilized by irradiation, which uses electron beam or gamma rays to produce a sterile and safe iv product per iso 11137-1 and iso 11137-2, international standards for the sterilization of health care products.These standards are recognized consensus standards by the fda, which are adhered to by bd to specify the requirements for the development, validation, and routine control of a radiation sterilization process.The irradiation process is known to modify polymers which causes some discoloring, depending on the applied radiation level (dose) and material choices.The degree or intensity of discoloration can also change over time, as it approaches shelf life, and under certain storage conditions such as high temperatures.Nonetheless, this type of discoloration is strictly cosmetic and does not affect the safety and functionality of the device as tested and sterilized.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16402153
• Report Number: 9616066-2023-00239
• Device Sequence Number: 5378700
• Product Code: FPA
• UDI-Device Identifier: 10885403235177
• UDI-Public: 10885403235177
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: 10/21/2025
• Device Catalogue Number: 30204E
• Device Lot Number: 22109399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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