MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET

Catalog Number 011-H3393

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return.It has not been received.

Event Description

The event involved a 28 cm (11") add-on set w/2 check valves, vented cap, non-dehp, that had a cytotoxic leak of between the second channel and the tubing.There were no clinical consequences noted.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The device history review (dhr) for lot 3981600 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.Additional information can be found in concomitant medical products.

• Brand Name: 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9147178
• MDR Text Key: 204570914
• Report Number: 9617594-2019-00326
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058043
• UDI-Public: (01)00840619058043(17)240201(10)3981600
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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: 02/01/2024
• Device Catalogue Number: 011-H3393
• Device Lot Number: STOPCOCK, I.V. SET22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1