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U.S. Department of Health and Human Services

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

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ICU MEDICAL, INC. TEGO CONNECTOR Back to Search Results
Model Number D1000
Device Problems Air Leak (1008); Infusion or Flow Problem (2964)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2016
Event Type  malfunction  
Manufacturer Narrative
Pending receipt of devices.
 
Event Description
Int'l. (b)(6) complaint received reporting air in line with unspecified dialysis set-ups where d1000 tego connectors were in use. The initial information received reports ". In three instances with three separate patients; air was observed being pulled into the circuit through tego cap. " the tego connectors were removed and replaced. There were no reported patient injuries, change in baseline condition and or adverse consequences. Additional event, device usage information as well as return status of the involved devices although requested has not been received.
 
Manufacturer Narrative
Device return: two used d1000 tego connectors were returned. Visual inspection (pre and post decontamination) of the as received tego connectors recorded blood between the body and the seal. Engineering pressure testing and analysis was performed. The results recorded both units leaked/failed seal integrity. Each of the tego connectors were than disassembled and the internal componentry evaluated. The report documented both tego units had damages/cuts 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 air in line with unspecified dialysis set-ups where d1000 tego connectors were in use. The initial information received reports ". In three instances with three separate patients; air was observed being pulled into the circuit through tego cap. " the tego connectors were removed and replaced. There were no reported patient injuries, change in baseline condition and or adverse consequences. Additional event, device usage information although requested has not been received. This is the mfs'. Follow up report to provide additional information and device return investigation results.
 
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Brand NameTEGO CONNECTOR
Type of DeviceTEGO 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 Key6080759
MDR Text Key59225645
Report Number2025816-2016-00104
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2021
Device Model NumberD1000
Device Catalogue NumberD1000
Device Lot Number3275467
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse
Removal/Correction Number2025816-09/01/2016-005-R

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