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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 011-D1005
Device Problem Disconnection (1171)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/01/2023
Event Type  malfunction  
Manufacturer Narrative
He device is expected to be returned for evaluation, however, it it not yet received.Section e1 - phone number - (b)(6).
 
Event Description
The event occurred on an unspecified date and involved a tego® connector which was reported to have had an unspecified problem.The reporter stated that the unspecified condition could lead to life-threatening bleeding.The customer stated that there was patient involvement, and unknown harm.Additional information was received on 14 november, 2023, and the customer stated there was a case where a patient was on dialysis, and there was a disconnection with tego connector and permcathcatheter.This new model of tego plug detached, causing relevant acute hemorrhage and relevant hemoglobin being effected due to hemorrhage.No information was provided as to whether or not medical intervention was necessary.
 
Manufacturer Narrative
The complaint of broken on item 011-d1005 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.Lot history review could not be performed due to lot number r16084 shared for this complaint doesn't exist, therefore the lot for this complaint is unknown.
 
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Brand Name
TEGO® CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX  22790
Manufacturer Contact
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key18315253
MDR Text Key330589038
Report Number9617594-2023-01133
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-D1005
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/14/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received12/29/2023
Supplement Dates FDA Received01/29/2024
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 Initial
Patient Sequence Number1
Treatment
PERMCATHCATHETER, MFR UNK
Patient Age79 YR
Patient SexMale
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