MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VAL; STOPCOCK, I.V. SET

Catalog Number 011-AM6136

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been received.E1 - customer telephone number: (b)(6).

Event Description

The event involved a 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer with list number where the customer had initially reported a vague issue with the device; the blue valve is remounted in the fitting and they had to the change the device because there was a lot of pressure on the central venous line, plus there had been sufenta on this line for 48 hours.Additional information was received on (b)(6) stating that there was a 24h delay in therapy.The therapy has not been completed, because there was a change of device.There was no blood loss considered clinically significant.There was no report of a leak.The patient was insufficiently sedated before the system changed but nobody was hurt as a consequence of this event.No other information was provided.

Manufacturer Narrative

Additional information was received that this record is a duplicate of cn-(b)(6).Please refer to this record for all pertinent information.Evaluation results will be submitted in due course under 9617594-2024-00109-01.

• Brand Name: 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VAL
• 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: 18507024
• MDR Text Key: 333321095
• Report Number: 9617594-2024-00028
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709092334
• UDI-Public: (01)00887709092334(17)281001(10)13786509
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-AM6136
• Device Lot Number: 13786509
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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: SUFENTA, MFR UNK.