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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEVA PHARMACEUTICAL INDUSTRIES LIMITED TEVADAPTOR® LUER LOCK ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

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TEVA PHARMACEUTICAL INDUSTRIES LIMITED TEVADAPTOR® LUER LOCK ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Model Number MG412114
Device Problem Disconnection (1171)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/16/2018
Event Type  malfunction  
Event Description
Both cstd components became disconnected along with the carefusion needle free valve (injection cap) that we use. The line became disconnected leaving the central line open and bleeding out. The patient was discovered because bed alarm went off. There have been several other disconnects where the cstd disconnects from the tubing and we are waiting on a product update to fix that issue.
 
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Brand NameTEVADAPTOR® LUER LOCK ADAPTOR
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
4545 n. ocean blvd.
unit 11a
boca raton FL 33431
MDR Report Key7897267
MDR Text Key121036974
Report Number7897267
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMG412114
Device Catalogue NumberMG412114
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2018
Event Location No Information
Date Report to Manufacturer09/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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