MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ5303

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 02/23/2023

Event Type  malfunction  

Manufacturer Narrative

A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.H.3.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 maxzero¿ multi-fuse pressure rated extension set with needleless connector iv had a loose connection to the hub of the intracath, causing contrast medium to leak out.This occurred with 2 iv sets during use, and this complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "new iv connector mz5303 with the white caps do not fully screw into the hub of the intracath.We have had at least 2 instances where the connection failed and the patient did not receive contrast because it leaked out.This appears to be manufactured differently than previous shipments of the same product.No harm occurred to the patient.What was the original intended procedure? : mri prostate with and without contrast".

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of connection issues could not be verified due to the product not being returned for failure investigation.A device history record review for model mz5303 lot number 22119226 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector iv had a loose connection to the hub of the intracath, causing contrast medium to leak out.This occurred with 2 iv sets during use, and this complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "new iv connector mz5303 with the white caps do not fully screw into the hub of the intracath.We have had at least 2 instances where the connection failed and the patient did not receive contrast because it leaked out.This appears to be manufactured differently than previous shipments of the same product.No harm occurred to the patient.What was the original intended procedure? : mri prostate with and without contrast".

• Brand Name: BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH 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: 16845332
• MDR Text Key: 314308920
• Report Number: 9616066-2023-00791
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: 10885403230561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ5303
• Device Lot Number: 22119226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Male