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

Catalog Number D1000

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, but has not yet been received.

Event Description

The event involved tego® connector when a ¿split¿ was noticed in the clear plastic around the ¿bung¿ where the syringe twists onto the device.The incident occurred before the patient was put on the dialysis machine, when the nurse was accessing the connector with a syringe.Blood loss was reported.There was delay in critical therapy, however, no medical or surgical intervention was required.The device was changed out/replaced with no further problems encountered.The patient returned to baseline condition; there was no adverse event reported as a consequence of this event.

Manufacturer Narrative

One used tego connector (list#: d1000, lot#: 4775688) was received and visually inspected; the seal was torn in the area of the thread posts.No other damage or anomalies were observed.The fluid path of the tego sample was accessed using a 3 ml syringe from icu medical inventory that was modified to allow for fluid path visualization.The fluid path was clear and no obstructions were identified.The reported condition was confirmed.The probable cause of the seal damage is due to overtightening during use.Dfu states: when using a luer slip connection, only insert half-way while turning slightly clockwise.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.D9: device was received for evaluation 18 january 2021.

• 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: 11013914
• MDR Text Key: 232199524
• Report Number: 9617594-2020-00541
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)250301(10)4775688
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 4775688
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3ML AND 10ML PLASTIPAK LUER LOCK SYRINGES, BD MFR.