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

Catalog Number	30262E
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was discolored.The following information was provided by the initial reporter with the verbatim: tubing is discolored, nursing discovered when grabbing for patient tubing.Did not reach the patient.
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 21029604.D4.Medical device expiration date: unknown.H4.Device manufacture date: 03-feb-2021.D4.Medical device lot #: 21129178.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H3.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 bd alaris smartsite extension set was discolored.The following information was provided by the initial reporter with the verbatim: tubing is discolored, nursing discovered when grabbing for patient tubing.Did not reach the patient.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28-aug-2023.Investigation summary: two sample of lot 21029604 and one sample of lot 22129178 was returned for investigation.Through visual inspection, the customer complaint was confirmed.The tubing was darker in color.A device history record review for model 30262e lot number 21029604 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 30262e lot number 21129178 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.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17654750
• Report Number: 9616066-2023-01823
• Device Sequence Number: 6256866
• Product Code: FPA
• UDI-Device Identifier: 37613203011489
• UDI-Public: (01)37613203011489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 30262E
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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