MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9060
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxguard¿ extension set with needleless y-site was blocked while flushing the y-site.This occurred an unspecified number of times.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "it took excessive force to flush the y-site.The difficulty appears to happen at the blue "stopper" that is in the port.I had two of these that this happened with overnight but have had this issue multiple times over the past couple of months as have other nurses.".
Event or Problem Description
It was reported that the bd maxguard¿ extension set with needleless y-site was blocked while flushing the y-site.This occurred an unspecified number of times.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "it took excessive force to flush the y-site.The difficulty appears to happen at the blue "stopper" that is in the port.I had two of these that this happened with overnight but have had this issue multiple times over the past couple of months as have other nurses.".
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by customer that "unable to draw labs thru as i normally do with iv start and it took excessive force to flush the y-site.I had two of these that this happened with overnight but have had this issue multiple times over the past couple of months as have other nurses." the customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mx9060 because a lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE
• 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: 15801181
• Report Number: 9616066-2022-01735
• Device Sequence Number: 3009975
• Product Code: FPA
• UDI-Device Identifier: 10885403237591
• UDI-Public: (01)10885403237591
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/19/2022

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: MX9060
• Device Lot Number: UNKNOWN
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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