MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0605320
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067); Thrombosis/Thrombus (4440)
Date of Event	02/11/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime later port placement procedure, the patient developed with unspecified infection and thrombosis.The current status of the patient was unknown.
Additional Manufacturer Narrative
H10: 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.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 after the port placement, the patient was diagnosed with an unspecified infection and thrombosis.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No medical records were provided for review.The investigation is inconclusive for the reported infection and thrombosis as no objective evidence was provided for review.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 b5, g3, h6 (component, method).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 litigation process that, on (b)(6) , 2007, a patient underwent port placement procedure via the left subclavian vein for intravenous access related to melanoma.Approximately one year eight months three days later, on (b)(6) , 2009, the patient was diagnosed with sepsis and thrombosis.It was further reported the device allegedly had obstruction of flow, and fibrin sheath formation was observed.Additionally, the patient was also diagnosed with bacterial infection, confirmed through blood culture.Subsequently, the port was removed on the same day.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation, medical record was provided for review.Medical report alleges that, a patient was implanted with bard port titanium implantable port for venous access for iv adjuvant chemotherapy of malignant melanoma via the left subclavian vein.One year, seven months and twenty four days later, patient had fever with port a cath injection.On injection of the port a cath contrast moved easily to the distal tip of the catheter.However, on exiting the catheter the collection around the tip in a somewhat lobular fashion.There is a delay in clearance of contrast from this region and was found consistent with peri catheter capsule or thrombus at its distal tip and was also found to have line sepsis.Subsequently, the port was removed on the same day.The distal tip of the catheter was cultured and was confirmed to be positive for gram positive cocci.Therefore, the investigation is confirmed for the reported obstruction of flow and device appeared to trigger rejection issues.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.B3, b5, g3, h6 (patient, device, component, method, result) 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: TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22033295
• Report Number: 3006260740-2025-03171
• Device Sequence Number: 8788282
• Product Code: LJT
• UDI-Device Identifier: 00801741025907
• UDI-Public: (01)00801741025907(10)RERD0259
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0605320
• Device Lot Number: RERD0259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 04/15/2026
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 02/12/2026; 04/21/2026
• 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: 41 YR
• Patient Sex: Female