MAUDE Adverse Event Report: B. BRAUN INTROCAN SAFETY IV CATHETER B BRAUN INTROCAN SAFETY IV CATHETER 20 G 1 1/4"

Lot Number 0061601142

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 11/01/2018

Event Type  Injury  

Event Description

Pt reported er visit and ultrasound indicated a retained iv catheter in vessel left wrist.Pt called facility on (b)(6) 2018 to inform us that he had gone to the er at (b)(6) hosp in (b)(6) for pain in left wrist.Pt has septoplasty and smr on (b)(6) 2018.He stated that ultrasound showed a retained iv catheter and he was referred to an orthopedic surgeon.Phone call taken by (b)(6) rn, administrator at approx 12:40 pm on (b)(6) 2018.

• Brand Name: B BRAUN INTROCAN SAFETY IV CATHETER 20 G 1 1/4"
• Type of Device: INTROCAN SAFETY IV CATHETER
• Manufacturer (Section D): B. BRAUN INTROCAN SAFETY IV CATHETER
• MDR Report Key: 8096930
• MDR Text Key: 128254513
• Report Number: 8096930
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/13/2018,11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061601142
• 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: 11/13/2018
• Distributor Facility Aware Date: 11/12/2018
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 86