MAUDE Adverse Event Report: C. R. BARD, INC. POWER MIDLINECATHETER; MIDLINE CATHETER

Model Number P4255108D

Patient Problems Low Oxygen Saturation (2477); Low Cardiac Output (2501); Foreign Body Embolism (4439)

Event Date 01/23/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024 the patient required a midline iv to be placed by a qualified interventional radiology registered nurse which was reported to have been inserted with no issues.On (b)(6) 2024, the patient's condition decompensated and she required an intensive care consult with additional oxygen need and vasopressors.A ct (computerized tomography) of the chest/abdomen/pelvis without contrast was ordered.In the reading there was noted to be a 'new linear metallic density within the right and left pulmonary arteries, favored to represent a foreign body such as a catheter or guidewire fragment'.A ct performed 3 days prior to the (b)(6) 2024 midline insertion did not show the foreign body.

• Brand Name: POWER MIDLINECATHETER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 18606579
• MDR Text Key: 334200130
• Report Number: MW5150869
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P4255108D
• Device Lot Number: REHT2959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White