MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") SET AMBRATO PER INFUSIONE 2 CLAVE® CONNECTOR, PERFORATORE CON FILTRO; STOPCOCK, I.V. SET

Catalog Number 011-H1367

Device Problem Disconnection (1171)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

It was reported that a 28 cm (11") set ambrato per infusione 2 clave® connector, perforatore con filtro, disconnected and caused a leak of unspecified chemo medication during patient use.The following issue was reported by the customer: ¿disconnection of the chemotherapy tree during placement of the chemotherapy bag.Clinical consequences noted: non-sterile device, leakage of chemo product.¿ the status of the product at the time of the event is during the placement of the chemotherapy bag.The cap of the chemotherapy tree was not sealed.When connecting the chemo bag to the blue cap (of the tree) it disconnected on its own at the weld.No chemo leak because the clamp was closed.No hole, no tear on the device before use.No need for medical intervention.The entire tree was changed.There was no patient harm reported.

• Brand Name: 28 CM (11") SET AMBRATO PER INFUSIONE 2 CLAVE® CONNECTOR, PERFORATORE CON FILTRO
• 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: 19008892
• MDR Text Key: 339159173
• Report Number: 9617594-2024-00350
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1367
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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