MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PowerPort isp Implantable Port, ChronoFlex Single-Lumen, 6F; Port & Catheter, Implanted, subcutaneous, Intravascular

Catalog Number	1706060
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Pain (1994); Skin Erosion (2075); Thrombosis/Thrombus (4440)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime post port placement procedure, the patient developed infection.However, the current status of the patient is 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 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) 2022, a patient underwent port placement via the left internal jugular vein for the treatment of colon cancer.Approximately two days later, on (b)(6)2022, the patient experienced pain at port site and was diagnosed with left internal and subclavian vein thrombosis, which was confirmed through an ultrasound.Additionally, approximately one month and three days later, on (b)(6)2022, the patient presented with erythema, purulent drainage at port site and port exposure.Blood cultures on the same day confirmed an infection.Subsequently, the port was removed on the same day, and a new port was implanted.Further, cultures from the medi port confirmed staphylococcus aureus bacterial infection.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 lot.Investigation summary: the physical device was not returned for evaluation.Medical records were provided for review.Medical record alleges that, a ppowerport isp implantable port was implanted in a patient via the left internal jugular vein for the treatment of colon cancer.Two days later, the patient presented with pain at port site.A subsequent duplex right upper extremity ultrasound revealed thrombosis of left internal jugular and subclavian veins.Thirty four days later the patient presented with erythema and drainage from the port site, which appeared to be purulent.The pus was drained and sent for culture.Additionally, it was observed that port was exposed.Blood cultures on the same day confirmed an infection due to vascular devices, implants.Subsequently, the port was removed on the same day.The investigation is confirmed for the reported infection, thrombosis, erythema, purulent discharge, pain and expulsion.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 (patient, device, 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: PowerPort isp Implantable Port, ChronoFlex Single-Lumen, 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: 21395505
• Report Number: 3006260740-2025-00744
• Device Sequence Number: 8292160
• Product Code: LJT
• UDI-Device Identifier: 00801741026546
• UDI-Public: (01)00801741026546(17)230430(10)REFU1467
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2026

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 1706060
• Device Lot Number: REFU1467
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 08/17/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Albuterol sulfate; Cymbalta; amlodipine besylate; carvedilol; gabapentin; glipizide; irbesartan-hydrochlorothiazide; metformin HCl
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female