MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") APPX 0.35 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP; STOPCOCK, I.V. SET

Catalog Number 011-MC3322

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

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however, has not yet been received.Additional reporter: (b)(6).

Event Description

The event occurred on various dates between november and december 2023 in the intensive care ward.The event involved a 15 cm (6") appx 0.35 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer where it was reported cracks occur in the luerlock coupling during use.It was unknown as to how many problematic devices were noted with the issue.There was no medication involved in the event and no chemo spill cleaned in the event per facility protocol.The patient/ health care provider was treated with painkillers.After using the product, the cracks were detected.There was a patient involvement but no patient harm.

Manufacturer Narrative

Received three (3) used.List #011-mc3322, ext set, smallbore bifuse, 2 clave¿ clear; lot #13611561.All three samples had cracks on the male luer threading.The reported complaint of a cracks on the luerlock could be confirmed.The returned samples all were cracked on the male luer.The probable cause of the cracking is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 15 CM (6") APPX 0.35 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: 18669859
• MDR Text Key: 336300075
• Report Number: 9617594-2024-00122
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC3322
• Device Lot Number: 13611561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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