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

Catalog Number	11448964
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	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 20 bd alaris¿ secondary sets from lot 21113390, and 1 set from lot 20093376 had issues with their tubing being discolored to brown.The following information was provided by the initial reporter: "tubing has turned a brown colour".
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 21113390, d.4.Medical device expiration date: 23-nov-2024, h.4.Device manufacture date: 18-nov-2021; d.4.Medical device lot #: 20093376, d.4.Medical device expiration date: 30-sep-2023, h.4.Device manufacture date: 30-sep-2020.H.3.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 20 bd alaris¿ secondary sets from lot 21113390, and 1 set from lot 20093376 had issues with their tubing being discolored to brown.The following information was provided by the initial reporter: "tubing has turned a brown colour".
Additional Manufacturer Narrative
H6: investigation summary one picture was submitted for quality investigation.The customer complaint of cosmetic issue - discolored was verified by evaluation of the photos submitted.The photo submitted by the customer shows that the drip chambers have different levels of a darker tint.A device history record review for model 11448964 lot numbers 21113390 and 20093376 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The 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¿ SECONDARY 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 ; 8448235433
• MDR Report Key: 17062131
• Report Number: 9616066-2023-01087
• Device Sequence Number: 15638127
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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 Catalogue Number: 11448964
• Device Lot Number: SEE H10
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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