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

Catalog Number D1000

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

The complaint/event involved a tego® connector that reportedly leaked.The reporter stated that there was leaking on the tego connector.When aspirating fluid with the catheter lock, air, blood and citrate came along with the syringe 7cc.The tego was connected on (b)(6) 2024 and removed on (b)(6) 2024.The disinfectant that was used is ethanol 70%.There was no medication involved in the event.No patient harm was noted to be associated with the complaint/event.

Manufacturer Narrative

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

Manufacturer Narrative

One used sample item # (b)(4) was returned by the customer for investigation.As received, the sample presented blood residual, however there was no physical damage, anomalies or visible occlusion in the fluid path.No mating device was returned for evaluation.The sample was tested as per procedure and failed the low / high pressure test.Once the sample was dissembled, a puncture inside the seal was found, no additional damage was observed.The customer's complaint of leakage can be confirmed based on the puncture observed on the device's seal.The probable cause is typical of access with a sharp instrument such as a needle during use.The dfu-3844 states: do not use needles or caps on tego.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9 date returned to mfg: 4/22/2024.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19046077
• MDR Text Key: 340108307
• Report Number: 9617594-2024-00373
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)280601(10)13663003
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K053106
• 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,Followup
• Report Date: 05/29/2024

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: D1000
• Device Lot Number: 13663003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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: CITRATE, MFR UNK.; ETHANOL 70%, MFR UNK.; UNSPECIFIED CATHETER, MFR UNK.; UNSPECIFIED SYRINGE, MFR UNK.