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

Catalog Number ME5301

Device Problem Obstruction of Flow (2423)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that bd maxguard pressure rated extension set was occluded the following information was received by the initial reporter with the verbatim another issue we have that we¿ve had reoccurring with a bd product is with a replacement item.Bd maxguard pressure rated extension set, ref (b)(4).Lot#23099089.Photo below.Fluids will not pass through from the blue cap side to the white.In testing one that we knew didn¿t work, i can see that the liquid starts to bubble up and gets clogged right at the white capped end.Force with two hands is required to push fluid passed it which you¿d never exert when using on the patient.Staff have not shared with me every occurrence, but i would say we¿ve had over 5.(b)(4).Tubing set purple extension male luer lock becton dickinson (b)(4).I received this product complaint below, regarding reference # (b)(4).I¿m not clinical, so not sure what other information you need to investigate.This product is only used in our apheresis dept, so no other areas are effected.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint that there was fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for model me5301 lot number 23099089 was performed.The search showed that a total of 22403 units in 1 lot number was built on 8sep2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional info: material#: me5301, batch number#: 23099089.It was reported by customer that in bd maxguard pressure rated extension set, ref me5301, lot#23099089 - fluids will not pass through from the blue cap side to the white.In testing one that they knew didn¿t work, they can see that the liquid starts to bubble up and gets clogged right at the white capped end.Force with two hands is required to push fluid passed it which never exert when using on the patient.Verbatim#: rcc received a complaint via email.Another issue we have that we¿ve had reoccurring with a bd product is with a replacement item.Bd maxguard pressure rated extension set, ref me5301.Lot#23099089.Photo below.Fluids will not pass through from the blue cap side to the white.In testing one that we knew didn¿t work, i can see that the liquid starts to bubble up and gets clogged right at the white capped end.Force with two hands is required to push fluid passed it which you¿d never exert when using on the patient.Staff have not shared with me every occurrence, but i would say we¿ve had over 5.1065011 tubing set purple extension male luer lock, becton dickinson me5301.I received this product complaint below, regarding reference # me5301.I¿m not clinical, so not sure what other information you need to investigate.This product is only used in our apheresis dept, so no other areas are affected.Customer reply: what is the date of event? began seeing this blockage in november and occurred throughout the use of the lot# describe any patient harm, injury, complication or negative outcome that occurred because of the event.No harm or patient impact, other than delay to grab another extension set.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? as they were full of liquid, all flawed sets were disposed of.I tested one before it was discarded.Solutions seem to start getting blocked shortly before the white cap.Excessive force is required to push it through which normally would not be used.

• Brand Name: BD MAXGUARD PRESSURE RATED EXTENSION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18432250
• MDR Text Key: 331912001
• Report Number: 9616066-2023-02481
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403230162
• UDI-Public: (01)20885403230162
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ME5301
• Device Lot Number: 23099089
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1