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 Break (1069); Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The complaint event occurred in the intensive care ward on an unspecified date in (b)(6)2023 and involved a 15 cm (6") appx 0.35 ml, smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer.The customer reported visible broken/missing pieces on the luer coupling/luer lock.There was no medication involved in the event.The patient/health care provider was treated with painkillers.The reported issue resulted in leakage during use.This was detected during routine checks inspections of the accesses.Although there was a patient connected to the defective device, there was no harm as a result of the complaint event.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Section e: additional contact: (b)(6).Category: manager.(b)(6), norway.(b)(6).

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 device history record 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: 18591755
• MDR Text Key: 334839266
• Report Number: 9617594-2024-00059
• 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
• 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: 01/26/2024
• 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?: No
• 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?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1