MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 237 CM (93") APPX 11.4 ML, 20 DROP 15 MICRON FILTER ADMIN SET W/FLOW CONTROLLER,; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-H3493

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer indicated that the device is available to return for investigation; it has not been received.

Event Description

The exact date of the event is unknown, but it occurred (b)(6) 2019.The customer reported that the main line broke in two while injecting medication.It broke in two at the build-in back check valve that is present on the main line, 5 cm from the injection point.There was patient involvement and an unspecified amount of blood loss occurred.There was no report of a medical intervention.

Manufacturer Narrative

H10: the date the device was returned to the manufacturer was 9/13/2019.The reported complaint of a broken in-line back check valve was confirmed.There was no manufacturing damage or anomalies identified that would have contributed to the breakage.The probable cause was due to an unintentional bending force during use.

• Brand Name: 237 CM (93") APPX 11.4 ML, 20 DROP 15 MICRON FILTER ADMIN SET W/FLOW CONTROLLER,
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 8936478
• MDR Text Key: 198330642
• Report Number: 9617594-2019-00286
• Device Sequence Number: 1
• Product Code: FMG
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3493
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1