MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S); 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 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22099253, medical device expiration date: 13-sep-2025, and device manufacture date: 09-sep-2022.Medical device lot #: 22089181, medical device expiration date: 09-aug-2027, and device manufacture date: 08-aug-2022.Initial reporter name and address: the customer's address is unknown.New jersey, usa has been used as a default.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd maxguard¿ pressure rated extension set with y-site(s) iv had a loose connection and leaked during use.This occurred once each in lots 22099253 and 22089181.The following information was provided by the initial reporter: "blue cap on the end has been changed to a clear cap and leading to connection issues, leaking of iv's, and several iv's to go bad.Was there any patient impact or patient involvement? yes, leakage around the cap and/or inability to remove cap which results in loss of iv and restick for patient.Did you experience any adverse events as a result of this reported defect? having to re insert second iv on patients".

Manufacturer Narrative

H6: investigation summary a complaint of the new luers causing connection issues and leakage was received.A photo of the two sets was returned by the customer.Connection issues and leakage could not be confirmed from the photos received.A device history record review for model mx5301 lot number 22099253 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mx5301 lot number 22089181 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

It was reported that the bd maxguard¿ pressure rated extension set with y-site(s) iv had a loose connection and leaked during use.This occurred once each in lots 22099253 and 22089181.The following information was provided by the initial reporter: "blue cap on the end has been changed to a clear cap and leading to connection issues, leaking of iv's, and several iv's to go bad.Was there any patient impact or patient involvement? yes, leakage around the cap and/or inability to remove cap which results in loss of iv and restick for patient.Did you experience any adverse events as a result of this reported defect? having to re insert second iv on patients".

• Brand Name: BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S)
• 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: 16230703
• MDR Text Key: 309057647
• Report Number: 9616066-2023-00049
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: 10885403237553
• 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: 01/26/2023

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: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/13/2023
• 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