MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SEE SECTION H10; STOPCOCK, I.V. SET

Catalog Number B33973

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 02/28/2024

Event Type  malfunction  

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 the clave (part of the 4-line manifold) became disconnected while magnesium was being hung; normal saline leaked out.This manifold was connected to a normal saline to keep open (tko).It was used for e-lyte replacement at the time.There was patient involvement, but harm was not reported as a consequence of this event.

Manufacturer Narrative

D1 - 14" (36 cm) appx 3.6 ml, transfer set w/4 clave¿, 2 tri-connectors, back check valve, clamp (blue), vented cap 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.

Manufacturer Narrative

No product samples, pictures, or videos were received for investigation, however, the reported condition of separation can be confirmed based on corrective actions already in process for b33973 can be confirmed.The probable cause is due to a manual bonding error manufacturing.Lot history review could not be reviewed due to the unknown lot number.

• Brand Name: SEE SECTION H10
• 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: 19031988
• MDR Text Key: 339236111
• Report Number: 9617594-2024-00360
• 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: 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: 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: 04/03/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MAGNESIUM, MFR UNK; NORMAL SALINE, MFR UNK