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

The complaint of cracks on item 011-mc3322 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The lot history was reviewed and no non conformities were found that would have led the reported condition on the 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: 18670927
• MDR Text Key: 334979173
• Report Number: 9617594-2024-00123
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058630
• UDI-Public: (01)00840619058630(17)280201(10)13557393
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: 13557393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1