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

Catalog Number	MX4450
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard extension set disconnected from the center/middle of the tubing.The following information was provided by the initial reporter: iv was disconnected in the middle of the tubing, not near any luer connection.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The initial reporter also notified the fda on 23-sep-2022.Medwatch report # (b)(4).
Event or Problem Description
It was reported that the bd maxguard extension set disconnected from the center/middle of the tubing.The following information was provided by the initial reporter: iv was disconnected in the middle of the tubing, not near any luer connection.
Additional Manufacturer Narrative
The following field was updated with additional information: h.6 medical device problem code (imdrf annex a code) - a0501.Investigation summary: no product or photo was returned by the customer.The customer complaint of separation in the middle of tubing, not near a connection, could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.Device history record review for model mx4450 lot number 22049030 was performed.The search showed that a total of (b)(4) 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 production build of this set.

• Brand Name: BD MAXGUARD 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15636026
• Report Number: 9616066-2022-01572
• Device Sequence Number: 7179111
• Product Code: FPA
• UDI-Device Identifier: 10885403274671
• UDI-Public: 10885403274671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/20/2022

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: MX4450
• Device Lot Number: 22049030
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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