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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); Fluid Leak (1250); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A review of the mfg. Lot database for the reported lot# 3255850 (mfg. 05/2016) showed (b)(4) units were mfg. Tested, inspected and released. There were no exception documents generated during the lot build. Pending receipt of involved and / same lot samples. Pending receipt of devices.
 
Event Description
Int'l ((b)(6) ) complaint received reporting leakages (blood/air) issues with use of d1000 tego connectors. The initial information received reports approximately five occurrences where tego connectors in use for one day were ". Leaking air and blood". There were no reported patient injuries and or adverse outcomes. Additional event information although requested by the mfr has not been provided.
 
Manufacturer Narrative
The involved tego connectors were not returned for analysis and confirmation. (b)(4) packaged d1000 tego connectors (none from the reported lot# 325580 and one from lot# 3246196) were received. Engineering analysis and investigation: the returned d1000 tego connectors were each pressure leak tested. The results recorded (b)(4) of the tego connectors leaked, failed pressure leak tests. Findings: the reported leakage issue was replicated and confirmed with (b)(4) of the returned complaint samples. 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 root cause(s) to be a seal component anomaly 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)(4)) complaint received reporting leakages (blood/air) issues with use of d1000 tego connectors. The initial information received reports approximately five occurrences where tego connectors in use for one day were ". Leaking air and blood". There were no reported patient injuries and or adverse outcomes. Additional event information although requested by the mfr. Has not been provided. This is the mfr's follow up report to provide additional information and the device return investigation results/findings.
 
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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 Key6019401
MDR Text Key57559223
Report Number2025816-2016-00153
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 08/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2021
Device Model NumberD1000
Device Catalogue NumberD1000
Device Lot Number3255850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2016
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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