MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SPECIALTY LOW-PRESSURE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX5302
Medical Device Problem Codes	Material Separation (1562); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device lot #: lot was reported; however, this is not a lot #2211980 manufactured for the reported catalog #.D.4 device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd specialty low-pressure extension sets experienced component separation.The following information was provided by the initial reporter: y site connection became disconnected while attached to the patient.
Event or Problem Description
No addtional information.
Additional Manufacturer Narrative
Investigation summary: 1 used and 1 unused sample were received and tested by our quality team.The used sample was clearly separated above the needless connector y-site (verifying complaint).Microscope analyses was used and there was a lack of solvent (glue) on tubing where it was inserted into the connector.The unused set had no issue after being pull tested and infused.The manufacturer was forwarded the information and concluded that the root cause was due to improper insertion by operator during the assembly of set.Unused set batch number was used for the device history record review: a device history record review for model mx5302 lot number 22119180 was performed.The search showed that a total of 14,403 units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.Lot of affected set unknown.

• Brand Name: BD SPECIALTY LOW-PRESSURE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17484371
• Report Number: 9616066-2023-01694
• Device Sequence Number: 17983657
• Product Code: FPA
• UDI-Device Identifier: 10885403237560
• UDI-Public: 10885403237560
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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 Catalogue Number: MX5302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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