MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number D1000

Device Problem Material Integrity Problem (2978)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The event involved a tego® connector.The customer reported that a home hemodialysis patient on-site for training was accessing her own central venous catheter (cvc) which had tego connectors on it (double lumen).She was having some difficulty getting the syringe into the tego.She finally got the syringe twisted into the tego and then when removing the syringe, she noticed the plastic was coming out of the device.The tego was newly applied and used on (b)(6) 2023.It was used again for dialysis on (b)(6) 2023.The tego was changed was able to proceed with dialysis.There was patient involvement but no patient harm.

Manufacturer Narrative

The device has been received for evaluation.Investigation is pending.E1 - initial reporter phone has an extension of (b)(6).Additional contact: (b)(6).

Manufacturer Narrative

A used d1000 tego connector was returned and confirmed to have seal tearing damage.Subsequent investigation showed that there was thread post damage typical of overtightening during use.No mating device was returned to evaluate with the damaged d1000 tego connector.The probable cause of the seal damage on the returned used d1000 tego connector is typical of over tightening during use.The directions for use (dfu) states: do not overtighten.A series of photos were returned showing a used d1000 tego connector with seal tearing damage.No mating device was shown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TEGO® CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 17365114
• MDR Text Key: 319931638
• Report Number: 9617594-2023-00418
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)271201(10)13481741
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: 13481741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• 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
• Treatment: CENTRAL VENOUS CATHETER (CVC), MFR UNK.; UNSPECIFIED SYRINGE, MFR UNK.
• Patient Sex: Female