MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Apheresis Port Access System; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	A710962
Medical Device Problem Codes	Difficult to Flush (1251); Fracture (1260); Device Appears to Trigger Rejection (1524); Improper or Incorrect Procedure or Method (2017); Suction Problem (2170); Obstruction of Flow (2423); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent port placement procedure using the powerflow apheresis port.On (b)(6) 2026, during a red blood cell exchange procedure, the healthcare worker reported successful access of the implanted port on the first attempt without difficulty.Blood return was obtained, and there was no pain or swelling at the port site upon initial access.After 107 ml of blood had been removed, air was identified in the inlet line.A clot was subsequently observed in the cartridge, and no flow was achieved following clot removal.Swelling was then noted in the patients body near the port during a flushing attempt.Additionally, there was an issue with aspiration and infusion.The port was explanted, and upon removal, a crack was reportedly observed in the port.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will 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 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: Apheresis Port Access System
• 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: 50472624
• Report Number: 3006260740-2026-06247
• Device Sequence Number: 18616543
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438(17)251031(10)REJT1799
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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 Expiration Date: 10/31/2025
• Device Catalogue Number: A710962
• Device Lot Number: REJT1799
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• 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 Sex: Unknown