MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET

Catalog Number B33973

Device Problems Disconnection (1171); Separation Problem (4043)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

Event Description

The event involved a 14" (36 cm) appx 3.6 ml, transfer set w/4 clave¿, 2 tri-connectors, back check valve, clamp (blue), vented cap where the customer reported that they had a defective tubing set that disconnects or separates.There was patient involvement but harm was not reported as a consequence of this event.

Manufacturer Narrative

No product samples, pictures, or videos were received for investigation, however, the complaint of a separation on the b33973 can be confirmed based on correction actions that are current in place for product.The probable cause is due to a manual bonding error in manufacturing.Lot history review for lot 5916735 was reviewed and no relevant non conformities were found that would have led to the reported complaint.

• Brand Name: 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V
• 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 ; CS 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19029477
• MDR Text Key: 339240433
• Report Number: 9617594-2024-00356
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709123984
• UDI-Public: (01)00887709123984(17)270401(10)5916735
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: B33973
• Device Lot Number: 5916735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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
• Treatment: METHOTREXATE, MFR UNK; NORMAL SALINE, MFR UNK; SODIUM BICARBONATE, MFR UNK