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

Catalog Number MX5301

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Initial reporter facility name: (b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd maxguard pressure rated extension set with y-site the iv connection was loose and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: the spot where the tubing screws into the catheter is stiff and does not twist all the time causing the iv to come out and the catheter to twist itself.

Manufacturer Narrative

Investigation summary no product or photo was returned by the customer.The customer complaint of issues with the catheter and iv connection could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material mx5301 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.

Event Description

It was reported while using bd maxguard pressure rated extension set with y-site the iv connection was loose and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: the spot where the tubing screws into the catheter is stiff and does not twist all the time causing the iv to come out and the catheter to twist itself.

• Brand Name: BD MAXGUARD PRESSURE RATED EXTENSION SET WITH Y-SITE
• Type of Device: 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: 16272741
• MDR Text Key: 308617678
• Report Number: 9616066-2023-00117
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403237550
• UDI-Public: (01)20885403237550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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
• Device Operator: Other
• Device Catalogue Number: MX5301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1