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 Problems Complete Blockage (1094); Defective Device (2588)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 maxplus¿ pressure rated extension set with removable needleless connector tubing presented resistance when attempting to thread a guidewire through, and a thin membrane was found inside that prevented the flow of fluid.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: we have defective product that need to be sent back to bd.Additional information received on 8-may-2023.I did take one of them last week and tried passing a guide wire through the tubing, at the luer lock that would attach to the iv hub i encountered resistance before feeling a ¿pop¿ sensation with the guide wire.Looking in the same end of other devices i see what appears to be a thin membrane preventing the flow of fluid in either direction.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 18-may-2023.H6: investigation summary : one sample of item mp5303-c, lot 23019105 was submitted for quality investigation.The customer complaint of tubing defective / damaged was verified by visual inspection.Evaluation of the sample submitted indicates that the fluid path in the extension set tubing looks to be partially occluded with solvent.Fluid flow was attempted by connecting the set to a syringe with water.Although there was flow through the tubing, fluid did not flow through the tubing freely and there was some restricting when trying to push fluids through the infusion set using a needless syringe.A device history record review for model mp5303-c lot number 23019105 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint is a manufacturing issue.A trend for the tubing defective / damaged issue has been identified for this product line.

Event Description

It was reported that the bd maxplus¿ pressure rated extension set with removable needleless connector tubing presented resistance when attempting to thread a guidewire through, and a thin membrane was found inside that prevented the flow of fluid.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: we have defective product that need to be sent back to bd.Additional information received on 8-may-2023 i did take one of them last week and tried passing a guide wire through the tubing, at the luer lock that would attach to the iv hub i encountered resistance before feeling a ¿pop¿ sensation with the guide wire.Looking in the same end of other devices i see what appears to be a thin membrane preventing the flow of fluid in either direction.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16959312
• MDR Text Key: 315862615
• Report Number: 9616066-2023-00946
• 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: 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: 06/15/2023

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: 23019105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• 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