MAUDE Adverse Event Report: BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9277
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12675851
• Report Number: 9616066-2021-52284
• Device Sequence Number: 11879857
• Product Code: FPA
• UDI-Device Identifier: 50885403240797
• UDI-Public: 50885403240797
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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