MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO CONNECTOR

Model Number D1000

Device Problems Air Leak (1008); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Mfg.Lot build review: a review of the mfg.Lot build database for the two reported lot# 2958834 (mfg.11/2014) showed (b)(4) units and lot# 2883691 (mfg.06/2014) also showed (b)(4) units were mfg.Tested inspected and released.There were no exception documents generated during the lot build.The involved devices or same lot samples were not returned for analysis and confirmation.The exact cause(s) of the reported event(s) issues are unknown at this time.The mfger.Will continue to monitor and trend these types of reported product issues and initiate preventative measures as applicable.Devices not returned.

Event Description

Int'l.(b)(6) complaint received reporting component damages/air in line with use of set-up consisting of gambro hospal 6 artisethd (ref.Hddnlhc / 115511) and tego connectors.Distributor (as translated ) reports two event/issues as follows "during a dialysis session, before the catheter connection noticed damages on the connector of the catheter with a crack, leading to air inlet.This defect seems due to the successive connections and disconnections of the tego cap used on the 2 catheter lumens.The tego cap seems to have a tight screw thread and obliges to use some strength to connect it on the connector of the catheter and impairs it.First thought that the catheter was the problem but we realized that is a connection issue, with the too tightly screwed tego caps." follow up information also reports the tego connectors were in use four days, where unspecified number of infusions, treatments were administered without issues.Medications/drugs administered identified as lovenox, aranesp, iron, heparine.There were no reported adverse patient consequences and or outcomes.Although requested no responses to requests for additional event information and status of device(s) available to be returned for investigation.

• Brand Name: TEGO CONNECTOR
• Type of Device: TEGO CONNECTOR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5925062
• MDR Text Key: 53906835
• Report Number: 2025816-2016-00077
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: 2958834; 2883691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GAMBRO HOSPAL 6 ARTISETHD (REF. HDDNLHC / (B)(4)