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 Separation Problem (4043)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Received a photo from the customer showing a microclave disconnected from the tree.Received one used.List #011-h1367, 28 cm (11") set ambrato per infusione 2 clave® connector, perforatore con filtro; lot #13500586.One (1) used.List #unknown, plum set; lot #unknown.The reported complaint of a separation could be confirmed.The microclave was separated from the tree fixture.The probable cause is from a lack of solvent during assembly in ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

Event Description

The event involved a 28 cm (11") set ambrato per infusione 2 clave® connector, perforatore con filtro where the investigation confirmed a separation on the returned sample.The event occurred at 11:01am at the pharmacy service.The customer reported a mismatch of the connection tip on the tree.The immediate measures done is completing line replacement.The event occurred while the device was used on a patient.No adverse events, no one was harmed, the therapy was not successful, no delay in therapy, no defects seen on the device before/after the event.No medication used during the event.No further additional information has been provided.

• 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: 18155088
• MDR Text Key: 328407736
• Report Number: 9617594-2023-00988
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619009342
• UDI-Public: (01)00840619009342(17)271201(10)13500586
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 13500586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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