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

Catalog Number	0605640
Medical Device Problem Codes	Degraded (1153); Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528); Material Too Rigid or Stiff (1544); Material Separation (1562); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
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.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 m.R.I.Ultra slimport.During the post port removal procedure, the surgeon experienced difficulty in removing the port, as the catheter appeared to adhere to the vein wall.It was further alleged that the catheter material felt harder and stiffer compared to that of a new port catheter.This raised concerns about a potential change in the catheter material properties over time.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one mri ultra slimport implantable port with an attached catheter in two segments and an additional catheter segment were received for evaluation.Gross visual, microscopic, tactile and functional evaluations were performed.A complete diagonal break was noted to the distal end of the attached catheter.The edges of the complete diagonal break on the distal end of the attached catheter were noted to be jagged.The surface was noted to be granular in one region and round/smooth in the other region.A complete diagonal break was noted on the proximal end of the distal catheter segment.The edges of the complete diagonal break on the distal end of the attached catheter were noted to be jagged.The surface was noted to be granular in one region and round/smooth in the other region.Splits were noted on the border of both regions.Catheter deformation was observed distal to the complete diagonal break on the distal catheter segment.Catheter degradation was observed throughout the proximal portion of the distal catheter segment.Catheter wear was also noted throughout the distal catheter segment.Therefore, the investigation is confirmed for the identified catheter fracture, material separation, wear, deformation and degradation issues.However, the investigation is inconclusive for the reported difficult to remove, material too rigid or stiff, entrapment of device as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.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.B5, g3, h6 (device, component, method, result, conclusion) 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 m.R.I.Ultra slimport on six months ago.On (b)(6) 2025, post the procedure while removal of the port from patients' body, the catheter tends to stick to the vein wall and gets stuck.This causes issues for the surgeon to remove the old port.They also observed the catheter material seemed harder and stiffer than a new port catheter suspecting change in material over time.Need to access the femoral site to access that part of the vein and slowly remove the catheter.There was no reported patient injury.

• Brand Name: M.R.I. ULTRA SLIMPORT 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: 23579520
• Report Number: 3006260740-2025-08734
• Device Sequence Number: 9305420
• Product Code: LJT
• UDI-Device Identifier: 00801741025990
• UDI-Public: (01)00801741025990
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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 Catalogue Number: 0605640
• Device Lot Number: UNKNOWN
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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