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

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.

• Brand Name: TEVADAPTOR® LUER LOCK ADAPTOR
• Type of Device: CLOSED 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 Key: 7897267
• MDR Text Key: 121036974
• Report Number: 7897267
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MG412114
• Device Catalogue Number: MG412114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2018
• Date Report to Manufacturer: 09/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA