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 Codes	Difficult to Flush (1251); Device Appears to Trigger Rejection (1524); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a port placement procedure using a powerport m.R.I.Isp.On (b)(6) 2026, during an outpatient visit, the port was accessed; however, medication could not be infused through the device.The port was subsequently removed, and a blood like substance was observed adherent near the valve slit at the catheter tip.Following transection of the catheter tip, patency was restored and normal flow was confirmed by flushing the port with normal saline.The obstruction was determined to be due to a clog at the catheter tip.It was reported that blood resembling a clot was adhering to the slit in the catheter valve at the time of removal.The device was retrieved for evaluation.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50144335
• Report Number: 3006260740-2026-05178
• Device Sequence Number: 13444359
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9808560
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/04/2026
• 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