MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, PUR CLEAR/YELLOW SMALLBORE QUADFUSE WITH 5 NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number 011-H2501

Device Problems Fluid/Blood Leak (1250); Separation Failure (2547)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The complaint/event occurred on an unspecified date and involved a ext set, pur clear/yellow smallbore quadfuse with 5 nanoclave¿.A leak at the soldering point (connecting the 4 channels into one) was detected on a new perfusion circuit.There was no report of human harm.

Manufacturer Narrative

The device history record was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Although the multiple attempts were requested for the device to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.If additional information becomes available, supplemental vigilance report(s) will be submitted at that time.

• Brand Name: EXT SET, PUR CLEAR/YELLOW SMALLBORE QUADFUSE WITH 5 NANOCLAVE¿
• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18298201
• MDR Text Key: 330133862
• Report Number: 9617594-2023-01110
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619018993
• UDI-Public: (01)00840619018993(17)280801(10)13738406
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2501
• Device Lot Number: 13738406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1