MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 M.R.I. Implantable Port, Hickman Single-Lumen, 9.6F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	0602660
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2009
Type of Reportable Event	Death
Event or Problem Description
It was reported through the litigation process that approximately ten months and twelve days after port placement procedure; the port catheter fractured and migrated into the left main pulmonary artery.Reportedly, the port and fractured catheter was removed.It was further reported that patient was expired, and the cause of death was not provided.
Additional Manufacturer Narrative
H10: the date of death for this patient was not provided; therefore, the date of death has been updated as 01-jan-1900 to meet the mdr submission requirement.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: M.R.I. Implantable Port, Hickman Single-Lumen, 9.6F
• Common Device Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
• Manufacturer (Section D): C.R. Bard, Inc. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• Manufacturer (Section G): Bard Reynosa S.A. de C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike gaffney ; 1415 w. 3rd street; tempe, AZ 85281
• MDR Report Key: 50947129
• Report Number: 3006260740-2025-99001
• Device Sequence Number: 10446270
• Product Code: LJT
• UDI-Device Identifier: 00801741025655
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0602660
• Device Lot Number: RESH1164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 09/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male