MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013072
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using the bd alaris medical infusion system administration sets the line broke from below the drip chamber.The following was recieved from the initial reporter: verbatim: customer reported occurred during patient use (within 5-10 minutes of treatment) ¿ no reported patient injury or medical intervention.Line was primed with normal saline as rn was trying to start chemo-before starting-the line broke from below drip chamber.
Additional Manufacturer Narrative
H6: investigation summary: a sample was received for investigation.Through visual inspection, the complaint of component damage was confirmed.The tubing was damaged below the drip chamber, causing the drip chamber to separate from the rest of the set.The tubing was also expanded where it had separated.A device history record review for model 10013072 lot number 22115368 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect, and an investigation was performed.After investigation and along with the manufacturing and quality operations team, the root cause that generates the issue of component damage ¿ no leak in model 10013072 is an incorrect assembly due to the personnel not following procedure.
Event or Problem Description
It was reported that while using the bd alaris medical infusion system administration sets the line broke from below the drip chamber.The following was recieved from the initial reporter: verbatim: customer reported occurred during patient use (within 5-10 minutes of treatment) ¿ no reported patient injury or medical intervention.Line was primed with normal saline as rn was trying to start chemo-before starting-the line broke from below drip chamber.

• Brand Name: BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17385989
• Report Number: 9616066-2023-01526
• Device Sequence Number: 15052687
• Product Code: FPA
• UDI-Device Identifier: 37613203021228
• UDI-Public: (01)37613203021228
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• 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): 07/28/2023

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: Health Professional
• Device Expiration Date: 11/17/2025
• Device Catalogue Number: 10013072
• Device Lot Number: 22115368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2022
• 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