MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATI; STOPCOCK, I.V. SET

Model Number B9259

Device Problem Air/Gas in Device (4062)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been discarded, however a sister sample is available for investigation but has not been received.Initial reporter facility name: (b)(6).

Event Description

The event occurred around 10:00 am and involved a 17" (43 cm) appx 5ml non-dehp ext set w/clave®, 0.2 micron filter, clamp, rotating luer.It was reported that during the induction of the patient there was a presence of air bubbles despite an air vacuum made rigorously to 2 inhales.The inhalo clamped the intravenous tubing as soon as they saw the air bubbles pass through the filter so the patient did not get any air.After the inhalo clamped the tubing they took an empty 10ml syringe and removed about 4ml of air, until there was a return of liquid without an air bubble.Once all the air bubbles were removed, the air bubbles no longer passed through the filter.There was patient involvement, however no report of patient harm.This captures the fifth of five events.

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.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATI
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14191188
• MDR Text Key: 289988672
• Report Number: 9617594-2022-00094
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709013292
• UDI-Public: (01)00887709013292(17)260201(10)5189886
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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 Model Number: B9259
• Device Catalogue Number: B9259
• Device Lot Number: 5189886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/24/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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