MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 M; STOPCOCK. I.V. SET

Model Number B33381

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer indicated that the device is not available for investigation.

Event Description

The event occurred on an unknown day in (b)(6) 2019.The clave on the prepared tubing was not secure and trained air into line.There was patient involvement, however, there was no adverse event.This report captures the first of 4 incidents.

Manufacturer Narrative

H10: no product samples, videos, or photographs were returned for investigation.The dhr was reviewed and there were no 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.The dhr for lot 3587835 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 M
• 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: 9217775
• MDR Text Key: 204572126
• Report Number: 9617594-2019-00350
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709008069
• UDI-Public: (01)00887709008069(17)221201(10)3587835
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: B33381
• Device Catalogue Number: B33381
• Device Lot Number: 3587835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1