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

Catalog Number	1708061
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not 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 litigation process that sometime later post port placement procedure, the port allegedly developed with catheter fracture.There was no reported patient injury.
Event or Problem Description
It was reported through the litigation process that, on (b)(6)2022, a port was implanted via the left subclavian vein in a patient due to a prior malfunctioning port, for the treatment of colon cancer.Approximately three months and sixteen days later, on (b)(6) 2022, the patient presented with pain in left arm and flushing issues with the port.A fluoroscopic evaluation of the device further revealed compromised integrity of the catheter at the level of the first rib and clavicle, with contrast extravasating from the catheter into the anterior chest wall.Furthermore, it was reported that the catheter had allegedly fractured.Subsequently, the port was removed on (b)(6)2022.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: additional information was identified in the medical record.Based on the identified information the file was reassessed for reportability and determined to be reportable as serious injury.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: although the physical device was not returned for evaluation, medical report was provided for review.Medical record review alleges that, powerport isp implantable port was implanted in a patient via the left subclavian vein for the treatment of colon cancer and due to prior malfunctioning port.Three months and sixteen days later, the patient presented with pain in left arm and flushing problem with the port.A fluoroscopic evaluation of the device on the same day revealed compromised integrity of the infuse a port catheter at the level of the first rib and clavicle, with contrast extravasating from the catheter into the anterior chest wall in this location.The malfunctioning port was removed one month and five days later.Therefore, the investigation is confirmed for the reported catheter fracture, difficult to flush and fluid leak issues.Furthermore, the clinical conditions alleged in the complaint can 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.B1, b3, b5, d4 (medical device lot #, unique identifier (udi) #), g3, h1, 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, 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: 21197541
• Report Number: 3006260740-2025-00060
• Device Sequence Number: 15525067
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072215
• 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): 03/11/2026

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 1708061
• Device Lot Number: REFY2009
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 06/11/2026
• 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: 49 YR
• Patient Sex: Female