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

Model Number MZ9277

Device Problem Leak/Splash (1354)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an product was not available for investigation; however the customer confirmed that the complaint sample lot number.From the information provided by the customer it appears that the customer experienced disconnection of an unknown syringe from the maxzero; no further details of the make and model of the syringe were available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for the provided lot number did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.

Event Description

It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector had spontaneous disconnection issues.The following information was provided by the initial reporter, translated from (b)(6) : "the product is not suitable for use because, for example, when rinsing, the syringe pops out even though it is well inserted in the connector.In addition, when it undergoes a continuous infusion and is carefully attached then it comes off." doubt; with the use of this product, venous cannulas become more prone to clogging.In addition, various syringes (e.G., luerlock and plain, etc.) are needed to ensure that the drug and fluid reach their destination.This usage problem has been detected in several wards at the new children's hospital.Previously, we had a ref 385102 bd q-ignition, there were no similar problems with this.Lot-batch number: 20067210.For information to be supplied by the supplier and the product complainant: hey, this is a complaint about the product you have supplied.After all, you will replace defective products with flawless products at your own expense.The advertised product is available, so if you want it examined, you can pick up the product from the location mentioned in the complaint or alternatively arrange for (b)(6) customer (= product location unit) an easy, appropriate and free return method.Please agree with the contact person of the product location unit, keeping (b)(6) aware of the measures until the matter is completed.We expect you to respond to this complaint within 5 business days and to take the necessary action within the time limit.Please reply to this message with all the recipients and subject.

• Brand Name: BD MAXZERO¿ MULTI-FUSE 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
• MDR Report Key: 12675851
• MDR Text Key: 277887319
• Report Number: 9616066-2021-52284
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403240797
• UDI-Public: 50885403240797
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: MZ9277
• Device Catalogue Number: MZ9277
• Device Lot Number: 20067210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2020
• 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