MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN PRIMARY SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Air/Gas in Device (4062)

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

Event Date 07/01/2023

Event Type  malfunction  

Event Description

The incident involved an unknown primary intravenous (iv) tubing set on an unknown date.It was reported that the rubber stopper becomes lodged inside the microclave after connecting the secondary tubing.This causes a proximal occlusion, a large amount of air to be pulled through, and the medication in the secondary line to backprime into the primary tubing.There was unknown patient involvement and unknown human harm.

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.E1: phone extension ext.(b)(4).

Manufacturer Narrative

The complaint of silicone sleeve stuck down could not 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 cause cannot be determined.The device history review (dhr) couldn't be performed due to lot number for this complaint was unknown.

• Brand Name: UNKNOWN PRIMARY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 17423474
• MDR Text Key: 320033393
• Report Number: 9617594-2023-00467
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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