MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PRESSURE TUBING - NON-STERILE - 6" LENGTH WITH POLYCARBONATE LUERS (REV. AC); STOPCOCK, I.V. SET

Catalog Number 0008-00-0293-09

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received for further investigation; however, testing of the device has not yet begun.

Event Description

It was reported that after inserting the iab and completing the procedure in the catheter room, there was no problem until returning to the patient room.After returning to the patient room, blood was collected every hour, and there was no problem until 2:00 am.However, when blood was collected at 3:00 am, the tube was disconnected from the connector part of the extension tube for pressure monitoring and bleeding occurred.After that, they removed the connector part and used another extension tube until iab was removed without any problem unknown.The reporter also stated there was bleeding but they don¿t specify the amount.There was patient involvement; however, there was no report of patient harm.

Manufacturer Narrative

The reported complaint of tubing disconnection/separation was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the 6" pressure tubing was found separated from the male luer.The tubing pocket appears to have sufficient uv adhesive present.The probable cause of the separation is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRESSURE TUBING - NON-STERILE - 6" LENGTH WITH POLYCARBONATE LUERS (REV. AC)
• 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: 11999215
• MDR Text Key: 256720510
• Report Number: 9617594-2021-00176
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0008-00-0293-09
• Device Lot Number: 4346712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1