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

Model Number 382634

Device Problems Material Puncture/Hole (1504); Retraction Problem (1536)

Patient Problem Bruise/Contusion (1754)

Event Date 09/10/2022

Event Type  malfunction  

Event Description

Registered nurse placed 20g heplock in right anterior chamber.Rn pushes white button to release needle and retraction only occurred partially.Iv pulled and iv was found to have the needle sheared through the plastic catheter.Patient did not receive injury.Slight bruising noted at site.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 15672594
• MDR Text Key: 302423502
• Report Number: 15672594
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382634
• Device Catalogue Number: 382634
• Device Lot Number: 2146298
• 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: 10/06/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White