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

Catalog Number	1808060
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Chest Pain (1776); Erythema (1840); Thrombosis/Thrombus (4440); Skin Infection (4544)
Date of Event	03/03/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: although the physical device was not returned for evaluation, medical report was provided for review.Based on the review of medical records, the patient underwent placement of a powerport implantable port via the right internal jugular vein for endocervical cancer treatment, with appropriate positioning and no immediate complications.Subsequently, the patient developed mild erythema with protrusion and a small open area at the port site, followed by a skin infection.Later, the port was removed, with complete extraction of the catheter and closure of the pocket, and the patient tolerated the procedure without complications.Therefore, it can be confirmed the material protrusion / extrusion and patient had experienced unspecified infection, thrombosis, erythema.However, the relationship to the port is unknown.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 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) 2015, a patient underwent port placement procedure via the right internal jugular vein for chemotherapy related to endocervical cancer.Approximately eighteen days later, on (b)(6) 2015, the patient was diagnosed mild erythema around the port.Additionally, some protrusion with a slight open area on the right side of port was reported.Approximately, one day later, on (b)(6) 2015, the patient was diagnosed with a skin infection.Approximately, one month and six days later, on (b)(6) 2015, the patient was diagnosed with chest pain.It was further reported that the patient developed blood clot.Subsequently, on (b)(6) 2015, the port was removed.However, the current status of the patient was unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 25481772
• Report Number: 3006260740-2026-04046
• Device Sequence Number: 9966096
• Product Code: LJT
• UDI-Device Identifier: 00801741027031
• UDI-Public: (01)00801741027031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 1808060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/12/2026
• 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: 44 YR
• Patient Sex: Female