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

Model Number D1000

Device Problems Air Leak (1008); Leak/Splash (1354)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Pending receipt of involved devices.

Event Description

Int'l.(b)(6) complaint received reporting leakage/air in lines with use of unspecified dialysis set-up where d1000 tego connectors were in use.The initial information received describes the event as follows ".Tego connector changed/protocol at beginning of the week.Once dialysis est.And running sm amt.Of blood started to ooze from side of tego.Machine stopped, tego changed 2nd tego once dialysis started blood oozed from side of tego, 3rd tego inserted into venous access line when with drawing blood with syringe could hear air so dialysis tubing line changed able to dialyze." there were no reported adverse patient consequences.

Manufacturer Narrative

Device return: two used d1000 tego connectors - return noted potential lot# as 3255580 visual inspection (pre and post decontamination) of the as received tego connectors recorded blood between the body and sheath on one unit; the second unit exhibited no observable external damage or evidence of leakage.Upon flushing, both tego connectors had clotting removed from the fluid path.Engineering pressure testing and analysis was performed.The results recorded both units leaked/failed seal integrity.Each of the tego connectors were disassembled and the internal componentry evaluated.The report documented damages to the one piece seal at the main seal interface.This condition could result in internal leakage.Corrective and preventative actions: a detailed analysis of the tego design, materials, manufacturing and inspection processes and equipment was performed.The data and engineering efforts identified the seal component anomaly was attributable to the manufacturing /molding operation involving a cavity core pin edge.Corrective actions have been identified, qualified and implemented.Additionally icu medical has initiated and is recalling those lots that could potentially contain this condition.

Event Description

Int'l.((b)(6)) complaint received reporting leakage/air in lines with use of unspecified dialysis set-up where d1000 tego connectors were in use.The initial information received describes the event as follows ".Tego connector changed/protocol @ beginning of the week.Once dialysis est.And running sm amt.Of blood started to ooze from side of tego.Machine stopped, tego changed 2nd tego once dialysis started blood oozed from side of tego, 3rd tego inserted into venous access line when with drawing blood with syringe could hear air so dialysis tubing line changed - able to dialyze." there were no reported adverse patient consequences.This is the mfgers.Follow up report to provide additional information and device return investigation findings.

• 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: 6087676
• MDR Text Key: 59466317
• Report Number: 2025816-2016-00169
• Device Sequence Number: 1
• Product Code: FPA
• 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: company representative,distri
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Removal/Correction Number: 2025816-09/01/2016-005-R
• Patient Sequence Number: 1