MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14"(36 CM)APPX3.6ML TRANSF SET W/4CLAVE 2TRI-CONNS BACKCHECKVALVECLMPBLUEVENTCAP; STOPCOCK, I.V. SET

Catalog Number B33973

Device Problems Disconnection (1171); Leak/Splash (1354)

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

Event Date 08/05/2023

Event Type  malfunction  

Event Description

The complaint/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.The 4-cap manifold was attached to the patient's maintenance intravenous fluid (mivf) with an unsecured cap.This was discovered when the nurse attempted to attach a intravenous piggyback (ivpb) bag of medication.The cap disconnected and intravenous fluid (ivf) sprayed onto the floor.It was further stated that all the other caps appear to be glued/securely attached to the tubing, but this cap was easily removeable leaving the tubing wide open to air.There was no human harm associated with the complaint/event.

Manufacturer Narrative

The device is not available for investigation.However, a photograph was provided by the customer and evaluation of the photo is pending.

Manufacturer Narrative

A photo was returned showing the clave separated from the bond pocket of the tri-connector.The reported complaint of separation can be confirmed on the b33973 transfer set w/4 clave.The probable cause is due to a manual bonding error in ensenada.The device history record could not be reviewed due to the unknown lot number.

• Brand Name: 14"(36 CM)APPX3.6ML TRANSF SET W/4CLAVE 2TRI-CONNS BACKCHECKVALVECLMPBLUEVENTCAP
• 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: 19043070
• MDR Text Key: 339564159
• Report Number: 9617594-2024-00367
• Device Sequence Number: 1
• Product Code: FMG
• 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: 04/16/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/16/2024
• 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: UNSPECIFIED INTRAVENOUS PIGGYBACK BAG, MFR UNK; UNSPECIFIED MAINTENANCE INTRAVENOUS FLUID, MFR UNK