MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number B4018

Device Problem No Flow (2991)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a 4-way high flow stopcock w/rotating luer where it was reported that 3 out of 3 bubble studies could not be completed as requested as the holes are not full holes in the actual stopcock.The customer stated they have had problems in nuclear medicine where the cardiolyte (nuclear material) is unable to be injected and will actually shoot back at the nuc med tech.There was unknown patient involvement, and unknown human harm.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Manufacturer Narrative

The complaint of no flow / can't prime / difficult to prime on item b4018 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 review (dhr) reviewed couldn't be performed due to lot number for this complaint was unknown.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• 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: 18410683
• MDR Text Key: 331520451
• Report Number: 9617594-2023-01203
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080077
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B4018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• 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
• Treatment: CARDIOLYTE, UNK MFR