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); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 08/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.Investigation is pending.

Event Description

The event involved a tego connector that the customer reported blood leaking out of the cap during treatment.The rn noted there was no tear/crack evident with visual inspection, however, it was noted that septum was broken/torn when the rn tried to attach blue tube, and flushed the tego cap during investigation.The customer stated it was not detected prior to use.There was 10 ml of blood loss, no property damage, and a medical or surgical intervention was required.The medical intervention required was the patient requiring blood cultures, and initiation of iv antibiotics due to possible line contamination, and the patient also required hospitalization for monitoring.The current patient status was returned to baseline after the incident.It was also mentioned that the device was replaced with no further problems encountered.There was patient involvement, but no serious injury, or death.This report captures the first of three devices.

Manufacturer Narrative

H10: received one used list# d1000, tego¿ connector.Lot# 4743519.The used d1000 tego assembly had seal tearing damage near the top surface of the seal.During functional testing the used d1000 tego assembly was confirmed to leak.The leakage was confirmed to come from tearing at the end of the slit on the top surface of the seal.The probable cause of the leakage is due to seal tearing damage, however, it is not known how the seal tearing damage occurred.No mating devices were returned to evaluate with the used d1000 tego assembly.A device history review (dhr) lot# 4743519 and relevant commodities were reviewed, and no non-conformances were found that would 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
• MDR Report Key: 10734506
• MDR Text Key: 213041575
• Report Number: 9617594-2020-00458
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)250301(10)4743519
• Combination Product (y/n): N
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: 4743519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSP DIALYSIS LINE, MFR UNK; UNSP DIALYSIS LINE, MFR UNK