MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SECONDARY SET C61; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515302
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 secondary set c61 the tubing clamp was missing.There was no report of patient impact.The following information was provided by the initial reporter: c61 was found without clamp before use.Same incident (same lot number) happened last month as well.
Additional Manufacturer Narrative
Product 515302, lot 1024992, qty 20.160, produced september 2022.Manufacturing process was conducted in accordance with document (b)(4) and all quality control activities have been performed according to quality specification 10-0160 and 10-0255.According to dhr, there were no quality notifications observed during manufacturing process related to customer complaint.Sample has not been received.Based on the picture provided from the customer, it can be confirmed customer experience (clamp was not present on product, code 6008).This defect is classified as c35 - imperfect assembly, incomplete which causes risk for patient and/or user.Retain sample have been examined and it can be confirmed that all components are present.There is no defect observed during this examination.After detailed investigation, it can be stated that this defect is caused by human error.Conclusion is that operator had a lack of concentration at the given moment, because this is the first complaint with the mentioned defect.If customer provide additional information that could help to conduct more detail investigation, investigation of this customer complaint will be revised, as needed.H3 other text : see narrative.
Event or Problem Description
No additional information provided.

• Brand Name: BD SECONDARY SET C61
• 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: 17597394
• Report Number: 9616066-2023-01778
• Device Sequence Number: 7421605
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020
• Combination Product (Y/N): Y
• Initial Reporter Country: MY
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 515302
• Device Lot Number: 1024992
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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