MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20" (51 CM) APPX 0.60 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number MC330279

Device Problem Air/Gas in Device (4062)

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

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

The event involved a 20" (51 cm) appx 0.60 ml, smallbore ext set w/microclave® clear, luer lock, where it was reported there is a defect that causes air to become trapped in the connector itself, releasing air into the central line.Our client was hospitalized 3 times.There was patient involvement and there was patient harm.This captures 3 out of 3 occurrences.

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review (dhr) lot # review was conducted, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 20" (51 CM) APPX 0.60 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, LUER LOCK
• 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: 17730121
• MDR Text Key: 323195528
• Report Number: 9617594-2023-00691
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709082083
• UDI-Public: (01)00887709082083(17)250501(10)4799947
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MC330279
• Device Lot Number: 4799947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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
• Patient Outcome(s): Life Threatening