MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA; STOPCOCK, I.V. SET

Catalog Number 011-AM6118

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The complaint event occurred on an unspecified date and involved a proximale 28 cm (11") smallbore ext set w/6-port nanoclave® manifold, check valve, nanoclave® (red rings), rotating luer.A leak was reported at the sealed ring of the proximal portal.There was no human harm reported with respect to this event, complaint.

Manufacturer Narrative

One used sample item #011-am6118 was returned by the customer for evaluation.As received, there was no physical damage nor anomalies observed on the returned sample.No mating device was returned.During the test, a leak from the adaptor and manifold's male luer was confirmed and no additional leaks were observed along the set were observed.The customer's complaint of leaks can be confirmed based on the physical used sample evaluation.The probable cause is due to an incomplete insertion during the manual process assembly of manufacturing.A review of the device history record could not be conducted because no lot number was identified.

Event Description

Additional information provided by the customer was received on (b)(6) 2024.The customer further reported that the event was observed during use on a patient.There was no adverse clinical consequences and nobody has been hurt.There was no delay in therapy.The drug administered was g5%.There was no unprotected exposure for the patient or healthcare professional.The leak did not come into contact with the patient due to the presence of a two-way valve.There was no hemodynamic impact for the patient.The patient received the full intended dose because the system has been changed as soon as the leak was detected.No other information was provided.

Manufacturer Narrative

Additional information: corrective action measures are being taken with respect to this issue/defect.

• Brand Name: PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA
• 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: 18712351
• MDR Text Key: 335478679
• Report Number: 9617594-2024-00158
• 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,Followup,Followup
• Report Date: 04/11/2024

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-AM6118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/19/2024; 04/08/2024
• Supplement Dates FDA Received: 03/11/2024; 04/11/2024
• 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: GLUCOSE 5%, MFR UNK; UNSPECIFIED LIQUID INFUSATE, MFR UNK