MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. Dual-Lumen Implantable Port, Leonard, 10F; Port & Catheter, Implanted, subcutaneous, Intravascular

Catalog Number	0607100
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920); Migration (4003)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067); Thrombosis/Thrombus (4440)
Date of Event	11/14/2003
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime later port placement procedure; the catheter allegedly had fractured, and the patient had also allegedly developed with infection and thrombosis.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f ¿ the information provide 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.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2003, a patient underwent port placement via the right internal jugular vein for parenteral nutrition.Approximately sixteen days later, on (b)(6) 2003, imaging of the chest revealed that tip of the catheter has migrated to the right atrium.Further, approximately fourteen days later on (b)(6) 2003, the patient was diagnosed with gram negative bacterial infection and sepsis.Subsequently, the port was removed on the same day, and a new port was implanted on (b)(6) 2003.However, the current status of the patient remains unknown.
Event or Problem Description
It was reported through litigation process that, on (b)(6) 2003, a patient underwent the port placement procedure via the right internal jugular vein for parenteral nutrition.During the implantation procedure, it was reported that guidewire could not thread to the catheter.Approximately sixteen days later, on (b)(6) 2003, imaging of the chest revealed that tip of the catheter has migrated to the right atrium.Approximately fourteen days later on (b)(6) 2003, patient was diagnosed with gram negative bacterial infection and sepsis.Subsequently, the port was removed on the same day, and a new port was implanted on (b)(6) 2003.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.B3, b5, d4 (medical device lot, unique identifier (udi) #), g3, h6 (patient, device, result, conclusion).Section a through f ¿ the information provide 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: although the physical device was not returned for evaluation, medical records were provided for review.Medical report alleges that, the port was replaced with a new bard port implanted port was implanted via right internal jugular vein.The old port a cath was removed, and the capsule was completely excised.Cultures were obtained from the wound bed and the area was irrigated with irrigation.An attempt was made to place the port a cath in the left infraclavicular subclavian vein, and the wire could not be cannulated.This had been noted to be thrombosed previously as well as an attempt on the left internal jugular vein without able to thread the catheter.As the previous port a cath was exposed and into the subclavian vein.A pocket was made more medially in the right chest wall.The right internal jugular vein was cannulated.The guidewire was inserted.Fluoroscopy revealed good position of the wire.The port a cath catheter was then brought into the subcutaneous fascia to the skin incision on the right neck.The catheter was trimmed along the anterior chest wall.It was aspirated with good blood flow.Fluoroscopy revealed good position of the catheter and chest x ray will be performed in the recovery room.Sixteen days later, patient had palpitations, imaging of the chest revealed that, tip of the catheter has migrated to the right atrium.So, the patient underwent a surgery to fix the port in a correct place.Two weeks later, patient was diagnosed with infected port with gram negative sepsis.Subsequently, the port was removed on the same day.The port a cath was elevated and removed, and the distal tip was sent for culture.The port a cath cavity was then elevated and completely excised.A triple lumen central line was placed for ongoing tpn and iv medications and blood draws.Therefore, the investigation is confirmed for the reported catheter tip migration issue.Furthermore, the clinical conditions alleged in the complaint, specifically bacterial infection and sepsis can be confirmed.A review of sterilization record was conducted in accordance with applicable quality system and regulatory requirements, and no nonconformances or anomalies were identified.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B1, b3, b5, g3, h6 (device, component, method, result, conclusion).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. Dual-Lumen Implantable Port, Leonard, 10F
• Common Device Name: Port & Catheter, Implanted, subcutaneous, Intravascular
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): Bard Reynosa S.A. de C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 21628760
• Report Number: 3006260740-2025-01557
• Device Sequence Number: 8925484
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K912702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2026

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: 0607100
• Device Lot Number: 22FN5305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/18/2026; 08/22/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/15/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female