MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 381423

Device Problem Retraction Problem (1536)

Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462)

Event Date 08/15/2018

Event Type  malfunction  

Event Description

Rn was inserting iv into patients left arm.Rn obtained access with bd insyte autoguard.Clicked button to retract needle, device clicked, rn pulled iv out laid on bed assuming needle retracted, grabbed extension tubing while connecting tubing and flushing iv felt a poke on distal right thigh noted iv insertion needle didn't retract and punctured self, bleeding.

• Brand Name: INSYTE AUTOGUARD
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 9450 south state street; sandy UT 84070
• MDR Report Key: 7836610
• MDR Text Key: 118880140
• Report Number: 7836610
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 08/27/2018

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: Health Professional
• Device Catalogue Number: 381423
• 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: 08/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32485 DA