MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 8F; Port & Catheter, Implanted, subcutaneous, Intravascular

Catalog Number	5616000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
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.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.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 sometime later port placement procedure, the patient developed with unspecified infection.The current status of the patient was unknown.
Event or Problem Description
It was reported through the litigation process that, on (b)(6)2022, a patient underwent port placement via the left subclavian vein for chemotherapy related to colon cancer.Approximately one month and twenty nine days later, on (b)(6) 2023, the patient presented with erythema and drainage over the left chest at the port site.Approximately one day later, on (b)(6) 2023, the patient was diagnosed with a bacterial infection, which was confirmed by port culture.Subsequently, the port was removed on the same day.Additionally, approximately three days later, on (b)(6)2023, the patient was diagnosed with a bacterial infection due to micrococcus and gram negative rods.It was further reported that the patient eventually expired.However, the cause of death was not reported.
Additional Manufacturer Narrative
H11: additional information was identified in medical records.Based on the review of the medical record, and the file was reassessed for reportability and determined to be reportable as death.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.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.B2, b3, b5, g3, h1, h6 (patient, 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: PowerPort ClearVUE Slim 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 22492551
• Report Number: 3006260740-2025-04756
• Device Sequence Number: 8094165
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 5616000
• Device Lot Number: REGT1698
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/01/2026
• 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: Death; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male