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 No Flow (2991); Air/Gas in Device (4062)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not yet been received.

Event Description

The event involved a tego¿ connector.As per the report the cvc tego connector cap plastic membrane ripped and collapsed inside, unable to flush or aspirate cvc.The impact of the incident is that the microbubbles and air leakage into dialysis line, unable to aspirate or flush cvc lumen.There was no unexpected or prolonged care happened and invasive procedure is not providedthere was patient involvement and no patient harm, not applicable or not reported.

Manufacturer Narrative

One (1) used sample item #d1000 was returned for evaluation.As received the seal was observed to be torn and a notorious damage on thread post was observed.An occlusion on the fluid path was observed because the seal collapsed inside the fluid path.No mating device was returned.Complaint of holes / cut/ torn can be confirmed.The probable cause is typical due to overtighten.According dfu statement - attach administration device or syringe by pushing straight into tego access device for infusion.When removing, apply the same clockwise turning motion.Do not overtighten.The lot history was reviewed and 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18611347
• MDR Text Key: 334844358
• Report Number: 9617594-2024-00068
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)280901(10)13767999
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: 13767999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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