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

Model Number MZ1000-07

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

Patient Problems Air Embolism (1697); Hemorrhage, Cerebral (1889); Convulsion, Clonic (2222)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the maxzero needleless connector caused an air embolism and fluid leakage that led to a seizure and prolonged hospitalization.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "stroke/cvae050301 - air embolism, hospitalization or prolonged hospitalization e0109 - convulsion seizure a050401 - fluid leak, insufficient information, testing of actual/suspected device, device discarded, no findings available, results pending completion of investigation, no problem detected d15 - cause not established".

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of air embolism and fluid leakage could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed because a valid lot number was not provided by the customer.

Event Description

It was reported that the maxzero needleless connector caused an air embolism and fluid leakage that led to a seizure and prolonged hospitalization.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "e0133 - stroke/cvae050301 - air embolismf08 - hospitalization or prolonged hospitalizatione0109 - convulsionseizure a050401 - fluid leaka26 - insufficient informationb01 - testing of actual/suspected deviceb18 - device discardedc20 - no findings availablec21 - results pending completion of investigationd14 - no problem detectedd15 - cause not established".

• Brand Name: 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 22244 ; MX 22244
• MDR Report Key: 11096462
• MDR Text Key: 233559913
• Report Number: 9616066-2020-20694
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230194
• UDI-Public: 50885403230194
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention