MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES; INTRAVASCULAR ADMINISTRATION SET

Model Number	515306
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd phaseal¿ iv bag/line access devices foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: problem description: opened a sealed package and noticed brown spots on the plastic - appears dirty, and not sterile.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes,.D10: returned to manufacturer on: 08-may-2023.H6: investigation summary: sample and photo received by our quality team for investigation.Upon visual evaluation, brown particle observed to be embedded on the spike.A device history review was performed for reported lot 2111204, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported while using bd phaseal¿ iv bag/line access devices foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: problem description: opened a sealed package and noticed brown spots on the plastic - appears dirty, and not sterile.

• Brand Name: BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES
• 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: 16740496
• Report Number: 9616066-2023-00684
• Device Sequence Number: 15088619
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 10/31/2025
• Device Model Number: 515306
• Device Catalogue Number: 515306
• Device Lot Number: 2111204
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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