MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO; STOPCOCK, I.V. SET

Catalog Number B33895

Device Problem Break (1069)

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

Event Date 07/28/2023

Event Type  malfunction  

Event Description

It was reported that a 107" (272 cm) transfer set w/dual check valve, microclave®, luer lock experienced a break.There was a breakage of the hard plastic portion of the microclave.The medication involved is not available at this time.There was no patient harm reported.This is the second of two events.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

Three (3) new and two (2) used samples list #b33895 were returned for evaluation.One of the used samples has a spiro connection.As received the tips of both used blue microclaves were observed to be broken and some beach marks and crazing marks suggesting environmental stress during use were observed.No damage on the new samples was confirmed.No mating device was returned for evaluation.Complaints of cracks can be confirmed based on the physical sample evaluation.The probable cause is typically due to environmental stress during use.A device history review (dhr) was conducted and no relevant commodities, discrepancies, or anomalies were found that might lead to the condition reported by the customer.

• Brand Name: 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO
• 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: 18065731
• MDR Text Key: 327290116
• Report Number: 9617594-2023-00933
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33895
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: UNSPECIFIED FLUID, UNK MFR