MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number MC9079

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.It is yet to be received.

Event Description

The customer reported a 17" ext set w/0.2 micron filter, microclave® clear, clamp, rotating luer that had air in the iv tubing when changing out the lines.No additional information was provided.

Manufacturer Narrative

Three (3) new list# mc9079, extension sets (lot# 4915987) were received on november 9, 2020 and visually inspected.As received, no damage or anomalies were seen on any of the returned sets.No used product or mating devices were returned.Each extension set was primed with water at gravity pressure and then leak tested according to product performance specifications.No leaks or air bubbles were seen.The reported complaint could not be replicated or confirmed.A device history review for lot# 4915987 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• Type of Device: STOPCOCK, I.V. 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: 10790770
• MDR Text Key: 214799681
• Report Number: 9617594-2020-00473
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709078161
• UDI-Public: (01)00887709078161(17)250601(10)4915987
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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 Model Number: MC9079
• Device Catalogue Number: MC9079
• Device Lot Number: 4915987
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1