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

Catalog Number	0604550
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Thrombosis/Thrombus (4440)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No medical records were provided for review.Therefore, the investigation is inconclusive for the reported infection as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.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.
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the patient was allegedly developed with unspecified infection.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.B5, d1, d4 (medical device catalog #, unique identifier (udi) #), g3, h6 (patient, 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.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2005, a patient was implanted with port via the left subclavian vein for chemotherapy treatment for recurrent cervical cancer.Sometime after the port placement, it was reported that the patient was diagnosed with an unspecified infection and thrombosis.Subsequently, the port was removed.However, the current status of the patient was unknown.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2005, a patient was implanted with port via the left subclavian vein for chemotherapy treatment for recurrent cervical cancer.Sometime after the port placement, it was reported that the patient was diagnosed with an unspecified infection and thrombosis.Subsequently, the port was removed.However, the current status of the patient was unknown.
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 record states that, the patient underwent an implantable port placement procedure via left subclavian vein using a bardport due to the need for vascular access as part of chemotherapy for recurrent cervical cancer treatment.Catheter tip was positioned at the junction between the superior vena cava and the right atrium, it was confirmed by fluoroscopic guidance.The investigation is inconclusive for the reported infection and thrombosis as no evidence was found in the provided report.A review of sterilization records, endotoxin testing results, and bioburden data 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, d4 (medical device lot #, unique identifier (udi) #), g3, h6 (device, 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. Hard Base 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 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: 22291602
• Report Number: 3006260740-2025-04039
• Device Sequence Number: 8319211
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 0604550
• Device Lot Number: 22EP5128
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 02/05/2026; 08/26/2026
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 03/04/2026; 08/28/2026
• 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: 51 YR
• Patient Sex: Unknown