MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 381434

Device Problems Retraction Problem (1536); Device Fell (4014)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/25/2019

Event Type  malfunction  

Event Description

Rn inserting 20g insyte.Once iv catheter advanced prior to fully removing needle from catheter, rn decompressed retracting needle, as per usual work flow.Then rn fully removed needle from catheter and decompressed retracting button, button remained decompressed, needle did not retract.Rn laid needle on bed while securing iv, patient moved leg, needle fell off bed and needle stuck into the top of the rns foot first passing through his shoe.Rn pulled needle out of top of shoe and foot.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8603392
• MDR Text Key: 144834024
• Report Number: 8603392
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: (01)00382903814343
• 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: 04/18/2019,04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381434
• Device Catalogue Number: 381434
• Device Lot Number: 8337693
• 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: 04/18/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other