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

Catalog Number	MPX5300-C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported while using bd maxplus pressure rated extension set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: customer reporter "we have discovered a potential defect/issue with the bd maxplus pressure rated extension set (mpx5300-c).The tubing easily detaches in two places, and detached during a ct contrast exam on a patient when contrast was administered.This resulted in spillage of blood and some contrast material.All it takes is a slight, gentle pull and the tubing detaches from both sides of the central connector.".
Event or Problem Description
It was reported while using bd maxplus pressure rated extension set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: customer reporter "we have discovered a potential defect/issue with the bd maxplus pressure rated extension set (mpx5300-c).The tubing easily detaches in two places, and detached during a ct contrast exam on a patient when contrast was administered.This resulted in spillage of blood and some contrast material.All it takes is a slight, gentle pull and the tubing detaches from both sides of the central connector.".
Additional Manufacturer Narrative
H6: investigation summary: photos representation of sample was provided and investigated for this complaint.It was reported by the customer that a potential defect/issue with the bd maxplus pressure rated extension set (mpx5300-c).Customer stated that the tubing easily detaches in two places.The photos verified the complaint and the separation described was clearly presented.The manufacturer was notified of this issue for further investigation.The possible root causes of this failure are due to improper use of solvent dispenser by the operator during that point in assembly.A device history record review for model mpx5300-c and lot number 22079201 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.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET
• Common Device Name: 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: 17192965
• Report Number: 9616066-2023-01241
• Device Sequence Number: 20244536
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: (01)10885403237218
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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
• Operator of Device: Other
• Device Catalogue Number: MPX5300-C
• Device Lot Number: 22079201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown