MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 168 CM (66") APPX 2.4 ML, PUR YELLOW SMALLBORE EXT SET, 3-PORT NANOCLAVE¿ MANIFO; STOPCOCK, I.V. SET

Catalog Number 011-AM3106

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a 168 cm (66") appx 2.4 ml, pur yellow smallbore ext set, 3-port nanoclave¿ manifold w/check valve, nanoclave¿, nanoclave¿ 4-way stopcock (red ring), rotating luer.It was reported a leak was observed on the device at the the level of the screw thread between the yellow icu tubing and the start of the ramp.No clinical consequences for the patient.No adverse event/human harm.No need of medical intervention.No one was harmed.The event happened while the device was in place.The treatment was not fully administered.No blood loss.Parenteral nutrition was involved.The medication did not come in contact with the patient and healthcare provider.No visible default on the device before use.No tear, no hole, no cut noticed.The lot number is unknown because the packaging was not preserved.

• Brand Name: 168 CM (66") APPX 2.4 ML, PUR YELLOW SMALLBORE EXT SET, 3-PORT NANOCLAVE¿ MANIFO
• 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: 19140705
• MDR Text Key: 340681083
• Report Number: 9617594-2024-00446
• Device Sequence Number: 1
• Product Code: FMG
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2024

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: 011-AM3106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• 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
• Patient Sex: Female
• Patient Weight: 1 KG