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

Model Number 381433

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2017

Event Type  Injury  

Event Description

Event was not witnessed by staff and details are provided by patient's statement: patient was lying in bed with arm hanging off side of bed.A visitor came to the door of the patient's room and when the patient turned over in bed, the angiocath became caught on something (unknown) and was pulled out of the patient's right antecubital space.Angiocath had been saline locked and was not connected to any fluids/medications at the time of the event.The angiocath had been secured in a standard fashion using the adhesives provided with iv start kit.A portion of the angiocath appeared to be broken off and retained in the patient.The patient was evaluated and sent to vascular surgery where ~1.8cm of the angiocath was retrieved from the patient's subcutaneous tissue.

• Brand Name: BD 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: 6739868
• MDR Text Key: 80899322
• Report Number: 6739868
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 381433
• Device Catalogue Number: 381433
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 126