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	07/05/2023
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: new set of c61 comes without clamp - missing component.Same batch of item reported another pir on 4 july 2023.
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: new set of c61 comes without clamp - missing component.Same batch of item reported another pir on 4 july 2023.
Additional Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 1024010.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a photograph was supplied to our facility to aid in our investigation.The photographs displayed a device that lacked a pinch clamp.This nonconformance has been confirmed.Based on the image our engineers were able to associate the root cause for this event with the manual assembly process.Human error can result in the clamp component not being attached to the device during assembly.

• 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: 17405117
• Report Number: 9616066-2023-01544
• Device Sequence Number: 12542985
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: 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: 07/05/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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