MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ1000-07

Device Problems Backflow (1064); Defective Component (2292)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported that bd maxzero needless connector was damaged.The following information was received by the initial reporter with the verbatim: for icare 299260: the patient stated they felt a splatter and the rn had blood on the facial mask.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional info: material#: mz1000-07 batch#: unknown.It was reported by the customer that they have another 2 reports with 2 isolated microclaves.Verbatim: we have another 2 reports with 2 isolated microclaves.I care numbers are (b)(6).I assume i need a new shipping label to send these new ones to you for interrogation? for icare (b)(6): the patient stated they felt a splatter and the rn had blood on the facial mask.Add info received ¿ can you please advise the material number and lot number of the affected product? unknown.¿ was there any medical intervention required to address the reported exposure? no.

Manufacturer Narrative

The customer reported that blood had back flowed and there was splatter on the nurse.One sample model mz1000-07 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The max zero connector was attached to a 10 ml bd syringe filled with water and flushed.No fluid blockage was observed.With the syringe still connected to the max zero connector the max zero connector was attached to a bd extension set.The set was flushed and the syringe was disconnected.No leaks or back flow was observed after the disconnection.The customer complaint that the blood had back flowed as the syringe disconnected was not verified.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see h10 below.

• Brand Name: BD MAXZERO 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18242489
• MDR Text Key: 330035416
• Report Number: 9616066-2023-02292
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: (01)10885403230196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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
• Device Operator: Other
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1