MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE CLEAR, NANOCLAVE T; STOPCOCK, I.V. SET

Model Number A1009

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer indicated that the device is not available for investigation.Without the returned device, a comprehensive failure investigation cannot be performed.If additional information is received, and supplemental report will be submitted.

Event Description

The event involved a smallbore extension set with a crack in the extension tubing where it has two wings.When the vacutainer is twisted on the blood starts leaking significantly no matter how much it is tightened.There was a patient involved, however, there was no injury as result of this event.This report captures the third of 3 incidents.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The dhr (device history review) for lot number 4536601 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: 7" (18CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE CLEAR, NANOCLAVE T
• 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: 9781257
• MDR Text Key: 202426783
• Report Number: 9617594-2020-00057
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709051058
• UDI-Public: (01)00887709051058(17)241201(10)4536601
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1009
• Device Catalogue Number: A1009
• Device Lot Number: 4536601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1