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

Model Number 381534

Device Problems Break (1069); Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problems Inflammation (1932); Thrombosis (2100); Foreign Body In Patient (2687)

Event Date 01/11/2017

Event Type  Injury  

Event Description

A 20g iv was placed by the iv nurse in the patient's left forearm without difficulty.Later that evening at approximately 11 pm, her nurse noted the iv was leaking.The iv nurse was contacted to evaluate.The dressing was removed and revealed the iv catheter was severed.The pink luer connector remained, but the rest of the catheter could not be located.The nurse checked the patient's arm, bed, floor and surrounding areas without finding the rest of the catheter.The medical team was notified.An upper extremity duplex revealed focal superficial thrombophlebitis in a superficial left forearm vein associated with an iv catheter, but no evidence of deep vein thrombosis.A vascular surgery consultation was obtained.The patient was taken to the operating room for excision of the left superficial forearm vein foreign body (intravenous catheter).A 1.5 ¿ 2 cm incision was made over the foreign body and it was easily removed.The foreign body was sent to pathology and no additional material was retained in the vein.The site was irrigated, inspected, closed used 6-0 monocryl, followed by a band-aid.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr.; franklin lakes NJ 07417
• MDR Report Key: 6263136
• MDR Text Key: 65248468
• Report Number: 6263136
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 381534
• Device Catalogue Number: 381534
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 64