MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1606062
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
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 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
The patient underwent a catheter placement procedure using powerport m.R.I isp for chemotherapy treatment related to colorectal cancer.The catheter was used as a chemotherapy access line and was no longer in use following completion of treatment, with intermittent flushing and backflushing performed for maintenance.Post the procedure on (b)(6) 2026, during a recent catheter removal procedure, the device completely fractured while traction was applied during removal with the port device being held, and the catheter was subsequently surgically removed from the insertion site.There was no reported patient injury.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 25091039
• Report Number: 3006260740-2026-03185
• Device Sequence Number: 15896997
• Product Code: LJT
• UDI-Device Identifier: 00801741026416
• UDI-Public: (01)00801741026416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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 Catalogue Number: 1606062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/30/2026
• 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