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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); 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.
 
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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 Key5925062
MDR Text Key53906835
Report Number2025816-2016-00077
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K053106
Number of Events Reported1
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 Received09/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD1000
Device Catalogue NumberD1000
Device Lot Number2958834; 2883691
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
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 Treatment Data
Date Received: 09/02/2016 Patient Sequence Number: 1
Treatment
GAMBRO HOSPAL 6 ARTISETHD (REF. HDDNLHC / (B)(4)
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