MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED CLAVE EXTENSION SET; NOT PROVIDED

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date between (b)(6)2023 to (b)(6)2023 involving an unspecified clave extension set where the customer stated the clave came away from the extension set resulting in the patients parenteral nutrition having to be discarded.The event happened during infusion.The operator of the device at the time of the incident was a healthcare professional.The remedial action taken was that one batch number was removed from ward areas within the trust but not 100% certain this is the correct batch number.There was patient involvement and unknown patient harm.This is the first of two events reported.

Manufacturer Narrative

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

• Brand Name: UNSPECIFIED CLAVE EXTENSION SET
• Type of Device: NOT PROVIDED
• 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: 18414380
• MDR Text Key: 332498155
• Report Number: 9617594-2023-01206
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/13/2023
• 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
• Treatment: PARENTERAL NUTRITION (PN), MFR UNK