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

Catalog Number	9808560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, a patient underwent a port placement procedure via the internal jugular vein using a powerport m.R.I.Isp.On (b)(6) 2025, the patient reported discomfort.On (b)(6) 2026, a catheter rupture was confirmed, and the catheter was removed on the same day.It was further reported that a rupture occurred within the subcutaneous tunnel in the neck, and removal procedures were carried out.During removal, while pulling the catheter from the port body, the catheter broke off midway.No residual material remained.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.However, the return of the sample is pending.The investigation of the reported event is currently underway.Section a through f: the information provided by bd represents all of 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
On (b)(6) 2023, a patient underwent a port placement procedure via the internal jugular vein using a powerport m.R.I.Isp.On (b)(6) 2025, the patient reported discomfort.On (b)(6) 2026, a catheter rupture was confirmed, and the catheter was removed on the same day.It was further reported that a rupture occurred within the subcutaneous tunnel in the neck, and removal procedures were carried out.During removal, while pulling the catheter from the port body, the catheter broke off midway.No residual material remained.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received that this complaint involves one device and one clinical event.The reported discomfort is a downstream outcome of the same catheter malfunction (fracture/material separation).Therefore, the file was reassessed for reportability, and there is no evidence of this device is determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.G3 section a through f: the information provided by bd represents all of 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 M.R.I. IMPLANTABLE PORT, GROSHONG 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: 24679629
• Report Number: 3006260740-2026-01870
• Device Sequence Number: 9726268
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512(17)240930(10)REGY2401
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 9808560
• Device Lot Number: REGY2401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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
• Patient Sex: Unknown