MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER; PRIMARY IV SET

Model Number MC9013

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

A user facility mandatory medwatch was received that stated ¿during chemotherapy administration, staff identified small leaks with the icu medical 0.2-micron filters on three separate occasions.Filters pulled off the shelf for review.No staff exposure noted¿.There was patient involvement and no adverse event or patient harm reported.This is the first of three events reported.

Manufacturer Narrative

H10: there were no product samples, videos, or photographs returned for investigation.The dhr for lot number 4799806 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER
• Type of Device: PRIMARY IV SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10537485
• MDR Text Key: 208563994
• Report Number: 9617594-2020-00401
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: (01)00887709039391(17)250401(10)4799806
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC9013
• Device Catalogue Number: MC9013
• Device Lot Number: 4799806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK.