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

Catalog Number MPX5302-C

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

It was reported while using bd maxplus pressure rated extension set with needleless connector and y-site the tubing broke and leakage occurred.This occurred 1 times.This is the 2nd of 2 reported instances.There was no report of patient impact.The following information was provided by the initial reporter: tubing broke off peripheral iv extension set.Patient experienced minor blood loss.There have been 4 other occurrences of the same incident.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.E.1.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary the customer reported the tubing broke off, and returned a photo of the incident.The photo verifies the failure as a separation below the smart site.The root cause could be determined despite no physical sample, these failures are almost always traced to solvent.Manufacturing team provided memo on actions completed, a quality notification was issued to reinforce the tubing handling method by personnel.A device history record review could not be performed on material mpx5302-c because the lot number is unknown.

Event Description

It was reported while using bd maxplus pressure rated extension set with needleless connector and y-site the tubing broke and leakage occurred.This occurred 1 times.This is the 2nd of 2 reported instances.There was no report of patient impact.The following information was provided by the initial reporter: tubing broke off peripheral iv extension set.Patient experienced minor blood loss.There have been 4 other occurrences of the same incident.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• 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: 17167411
• MDR Text Key: 317967047
• Report Number: 9616066-2023-01216
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403237239
• UDI-Public: (01)20885403237239
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MPX5302-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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