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 Material Integrity Problem (2978)

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

Event Date 05/28/2023

Event Type  malfunction  

Event Description

It was reported that a168 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 was found with the emergency line valve pressed, during infusion, and not usable for at least 48 hours.Additionally, the patient has an ¿arm catheter, placed centrally, since may 15,(b)(6) 2023.Iccu 8, changed on may 26, 2023.Continuous treatments: parenteral administration, fentanyl and hypnovel respectively at 6.5 ml/h; 0.3ml/h and 0.3ml/h.Discontinuous treatments: perfalgan and atb¿.There was no harm reported.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint was confirmed.The nanoclave on the nanoclave stopcock was observed to be stuck down and subsequent disassembly revealed a bent spike and torn seal.The probable cause of the seal sticking down is typical of access with an incompatible mating device during use.The dfu states: that needle free connectors are compatible with iso male luers having an internal diameter between 0.062 inches (1.58 mm) and 0.110 inches (2.8 mm).A device history review (dhr) could not be conducted because no lot number(s) was/were identified.Additional information: d9 - date returned to mfg - 9/14/2023.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17548934
• MDR Text Key: 321182791
• Report Number: 9617594-2023-00552
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• 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
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: ARM CATHETER PLACED CENTRALLY MAY 15, 2023 UKN MFR; FENTANYL 0.3ML/H, UNK MFR; HYPNOVEL 0.3ML/H, UNK MFR; PARENTERAL ADMINISTRATION 6.5 ML/H, UNK MFR; PERFALGAN, UNK MFR; UNSPECIFIED ANTIBIOTICS (ATB), UNK MFR
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 1 KG