MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1859660
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Ulcer (2274)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photo was provided for review.The investigation of the reported event is currently underway.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
A patient underwent a port placement procedure using the mri powerport isp.On (b)(6) 2025, post the port placement, it was reported that the catheter was allegedly leaking on the back plate, and the patient allegedly experienced pain and skin ulceration.The port was removed, and a new port was implanted.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: this supplemental mdr is being submitted to provide updated information that was not known or fully available at the time of the original mdr submission.The event involves a single implanted port associated with a catheter malfunction including material puncture, fluid leak, obstruction of flow.Subsequent information confirmed downstream clinical outcomes including pain and skin ulceration and chemotherapy extravasation that required medical intervention.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: one powerport isp mri implantable port attached to a catheter was returned for evaluation and three photos were provided for review.The first photo shows the patient skin in which wound was observed.The second photo show partial view of a port with attached catheter in which fluid was inserted through right angle non-coring needle into port septum and fluid leaking from the backside of the implantable port.The third photo show partial view of a catheter placed inside a plastic packet.Gross visual, microscopic, tactile, functional evaluations were performed.A pinhole was noted on the center area of the back portion of the port.The port septum was removed from the port body for further evaluation.Upon removing the port septum, appeared to be thrombus, was noted throughout the inside of the port body.The pinhole was visible within the port body.The port septum was further inspected and appeared to have multiple puncture access throughout.The port was patent to both infusion and aspiration without issue.Therefore, the investigation is confirmed for the reported fluid leak and identified material puncture/hole issues.However, the investigation is inconclusive for the reported obstruction of flow issue as the sample evaluation results indicating no issue in infusion and aspiration under laboratory conditions may not be representative of the condition of the device during use.The definitive root cause could not be determined based upon available information.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, method, result, conclusion).This supplemental mdr updates the original report to reflect confirmed clinical outcomes and investigation results associated with the same device event.No additional or separate adverse event occurred.All information is related to the initial malfunction previously reported under this manufacturer's report number.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
A patient underwent port placement procedure using the mri powerport isp on (b)(6) 2024.It was reported that on (b)(6) 2025 post the port placement in the right chest wall via internal jugular vein, the port was allegedly found leaking on the back plate.It was further reported that patient allegedly experienced pain and skin ulceration and pain, skin ulceration occurred because extravasation of the chemotherapy.On (b)(6) 2025, the device was removed.However, the current status of the patient was unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23874980
• Report Number: 3006260740-2025-09986
• Device Sequence Number: 17535540
• Product Code: LJT
• UDI-Device Identifier: 00801741027222
• UDI-Public: (01)00801741027222(17)250831(10)REHY1231
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 08/31/2025
• Device Catalogue Number: 1859660
• Device Lot Number: REHY1231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown