MAUDE Adverse Event Report: C. R. BARD, INC. POWERGLIDE PRO MIDLINE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS

Model Number	F320087T
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Midline catheter inserted in the right cephalic vessel under ultrasound guidance.Vessel accessed and guidewire advanced without resistance.As the catheter was advancing, resistance noted and catheter was pulled back and a popping sound was heard.Catheter was pulled out and noted that the wire was sheared and not intact.Stat x-ray revealed a 4 cm linear metal object within the anterolateral arm.Pt was transported to diagnostic imaging for retrieval of the wire foreign body.Retrieval was successful with no harm to the pt.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8666214
• Report Number: MW5087093
• Device Sequence Number: 18904962
• Product Code: FOZ
• UDI-Device Identifier: 00801741140525
• UDI-Public: (01)00801741140525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: F320087T
• Device Catalogue Number: F320087T
• Device Lot Number: RECT1271
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 113