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 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.E.1.Initial reporter state: address information was not able to be obtained, therefore, ma was used as a place holder based off user facility.H.4.Device manufacture date: unknown.

Event Description

It was reported that during use with bd maxplus pressure rated extension set with needleless connector and y-site the tubing broke and patient/s experienced minor blood loss.This occurred 4 times, however, information regarding patients was not able to be obtained.Patient had to have iv replaced.This is the 1st of 2 incidents being reported.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.Additional info receive on 24may2023.Are you able to provide batch number of the defective sets? no.Are all 4 defectives items from same lot? unknown.Are this the first report to bd on this issue for all 4 occurrences? this is the first report.We have asked rns to fill out an incident report if it occurs again.Can you identify date of occurrence of all 4? no.Could you describe any medical intervention performed to the patient? replaced iv.Any adverse event observed from the patient? no.

Event Description

It was reported that during use with bd maxplus pressure rated extension set with needleless connector and y-site the tubing broke and patient/s experienced minor blood loss.This occurred 4 times, however, information regarding patients was not able to be obtained.Patient had to have iv replaced.This is the 1st of 2 incidents being reported.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.Additional info receive on 24may2023 are you able to provide batch number of the defective sets? no.Are all 4 defectives items from same lot? unknown.Are this the first report to bd on this issue for all 4 occurrences? this is the first report.We have asked rns to fill out an incident report if it occurs again.Can you identify date of occurrence of all 4? no.Could you describe any medical intervention performed to the patient? replaced iv.Any adverse event observed from the patient? no.

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.

• 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: 17163095
• MDR Text Key: 318128408
• Report Number: 9616066-2023-01215
• 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: Health Professional
• 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