MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP; STOPCOCK, I.V. SET

Catalog Number 011-MC33869

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/23/2023

Event Type  malfunction  

Event Description

The incident involved a 5" (13 cm) appx 0.33 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer.The reporter stated that the nursing staff in the hospitalization area detected that during the administration of the medication, the product was leaking in the area near the insertion local and proceeded to remove it.The event occurred during patient use, and there was no harm as a result of this event.

Manufacturer Narrative

E1: (b)(6) the device has been requested to be returned for evaluation; however, it has not yet been received.

Manufacturer Narrative

One (1) used sample #(b)(6) was returned for evaluation.As received no physical damage was observed, only the marks on the tubes indicating that the clamps were activated, were observed.No mating device was returned for evaluation.The set was tested as per procedure and no leaks along the device were confirmed.The male luer was measured and was found within specification.The complaint of leaks cannot be confirmed based on the evidence provided by the customer.The device history review (dhr) for lot#12887742 was reviewed and no non conformities were found that would have led the reported condition on the complaint.

• Brand Name: 5" (13 CM) APPX 0.33 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP
• 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: 18217914
• MDR Text Key: 329137021
• Report Number: 9617594-2023-01035
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619081133
• UDI-Public: (01)00840619081133(17)271101(10)12887742
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33869
• Device Lot Number: 12887742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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