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	Difficult to Flush (1251); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three years and two days post a port placement, the blood was allegedly not able to be drawn or transfused.Reportedly, the port was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.H11: 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.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one mri ultra slimport implantable port attached to a catheter in two segments were returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in-house syringe with dye water was attached to a safety infusion set and the non-coring needle was inserted into the port septum.Infusion was attempted but was unsuccessful.Aspiration was attempted and was unsuccessful as neither water nor air did not return to attached syringe.A 0.018in x 150cm boston scientific starter guidewire was inserted into the port stem to expose any material within the port body.Resistance was felt on the first attempt when guidewire was entered.An infusion test was performed and was successful and aspiration was was successful as dye water fully returned into the attached syringe.The catheter was reloaded to the port body and another test was performed.The port body was patent to both infusion and aspiration without issue.However the investigation is inconclusive for the reported flushing and suction issues as the exact circumstances at the time of event was unknown.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.H11: 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
It was reported that three years and two days post a port placement, the blood was allegedly not able to be drawn or transfused.Reportedly, the port was removed.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 attached to a catheter in two segments were returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in house syringe with dye water was attached to a safety infusion set and the non coring needle was inserted into the port septum.Infusion was attempted but was unsuccessful.Aspiration was attempted and was unsuccessful as neither water nor air did not return to attached syringe.A 0.018in x 150cm boston scientific starter guidewire was inserted into the port stem to expose any material within the port body.Resistance was felt on the first attempt when guidewire was entered.An infusion test was performed and was successful and aspiration was successful as dye water fully returned into the attached syringe.The catheter was reloaded to the port body and another test was performed.The port body was patent to both infusion and aspiration without issue.However, the investigation is inconclusive for the reported flushing and suction issues as the exact circumstances at the time of event was unknown.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.G2, g3, h6 (component).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
It was reported that three years and two days post a port placement, the blood was allegedly not able to be drawn or transfused.Reportedly, the port was removed.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: 21300492
• Report Number: 3006260740-2025-00294
• Device Sequence Number: 18354933
• Product Code: LJT
• UDI-Device Identifier: 00801741025990
• UDI-Public: (01)00801741025990
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 03/20/2026
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/29/2025; 03/30/2026
• 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