MAUDE Adverse Event Report: BD SAF-T-INTIMA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/02/2017

Event Type  malfunction  

Event Description

Rn attempted iv insertion with intima #22gauge iv.When removing needle from patient, the cover on the device failed to cover needle, and the needle bounced back and stuck rn in the forearm.

• Brand Name: SAF-T-INTIMA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD; 5859 farinon dr; ste 200; san antonio TX 78249
• MDR Report Key: 6951536
• MDR Text Key: 89410423
• Report Number: 6951536
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other