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

Catalog Number MZ1000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a maxzero needleless connector had foreign matter before use.The following was reported by the initial reporter: "has presented a foreign matter, package still sealed.".

Event Description

It was reported that a maxzero needleless connector had foreign matter before use.The following was reported by the initial reporter: "has presented a foreign matter, package still sealed.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/27/2021.H.6.Investigation: a mz1000 sample from lot 19095095 was received for investigation in opened packaging; no signs of previous usage was identified.A visual inspection of the sample confirmed the customer's experience as a dark contaminant was visible trapped between the piston and the housing of the maxzero.Ftir analysis of the returned sample did not conclusively confirm the exact nature of the contamination, however it was confirmed during analysis that it was likely to be burnt inorganic material.A review of the manufacturing process did not identify any obvious potential sources for contamination of this nature and a definitive root cause could not be determined.A review of the production records for lot 19095095 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• 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: 11143570
• MDR Text Key: 250777138
• Report Number: 9616066-2021-50008
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Catalogue Number: MZ1000
• Device Lot Number: 19095095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/09/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1