MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP5303-C

Device Problem Obstruction of Flow (2423)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported while using bd maxplus pressure rated extension set with removable needleless connector there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: additional samples were received from the customer with the below defect.Mp5303-c - qty 3 lot 22109023- in sample 3 flow issue -fluid blockage observed and verified.

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.H.3.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 maxplus pressure rated extension set with removable needleless connector there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: additional samples were received from the customer with the below defect.Mp5303-c - qty (b)(4) lot 22109023- in sample 3 flow issue -fluid blockage observed and verified.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-apr-2023.H6: investigation summary: total 4 different samples set were received with the related complaint this new complaint was created for sample 3 (mat # mp5303-c).Three samples received from customer for this complaint.Prior to functional testing the sets were visually examined for defects and abnormalities.No defects or abnormalities were observed.The sets were connected to a 10 ml bd syringe filled with water and attempted to be flushed.The samples showed signs of occlusion at the female luer adapter connected to the maxplus connector.The sets were examined under a microscope and excess solvent was observed near the female luer which caused the backflow.The customer complaint could be replicated.Quality notification sent to manufacturer.A device history record review for model mp5303-c and lot number 22109023 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
• 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 ; 8448235433
• MDR Report Key: 16725687
• MDR Text Key: 313650137
• Report Number: 9616066-2023-00673
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403236652
• UDI-Public: (01)20885403236652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 05/01/2023

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: MP5303-C
• Device Lot Number: 22109023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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