MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MINIBORE PRESSURE RATED EXT, IV CNNCTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number MZ5301

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the minibore pressure rated ext, iv connector was blocked/occluded and couldn't apply fluids.This occurred 50 separate times during use.The following information was provided by the initial reporter: "customer wasn't able to applied fluids over connector.After disconnecting infusion was possible.".

Manufacturer Narrative

H6: investigation summary two mz5301 samples from lot 19116785 were received for investigation; one inside its sealed packaging and in opened packaging.A visual inspection did not identify signs of damage or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by separately connecting each sample to a bd luer slip syringe and a bd 50ml plastipak syringe from retained stock and flushing with fluid; flow restriction or complete occlusion was not identified during testing.Furthermore, pressure fluid was applied from the male luer component; no leakage or issues were identified during pressure testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 19116785 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz5301 product in the past 12 months.

Event Description

It was reported that the minibore pressure rated ext, iv connector was blocked/occluded and couldn't apply fluids.This occurred 50 separate times during use.The following information was provided by the initial reporter: "customer wasn't able to apple fluids over connector.After disconnecting infusion was possible.".

• Brand Name: MINIBORE PRESSURE RATED EXT, IV CNNCTOR
• 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: 11089400
• MDR Text Key: 229593844
• Report Number: 9616066-2020-20669
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230545
• UDI-Public: 50885403230545
• 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,Followup
• Report Date: 01/14/2021

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: Other
• Device Expiration Date: 11/22/2022
• Device Model Number: MZ5301
• Device Catalogue Number: MZ5301
• Device Lot Number: 19116785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1