MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1606052
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) a patient underwent a port placement procedure using powerport clearvue isp implantable port, chronoflex single-lumen, 8f into the right subclavian vein.On (b)(6) 2025, it was reported that the port body and catheter connection was allegedly found detached.There was no reported patient injury.
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 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one power port clear vue isp implantable port, one catheter and one cath-lock were returned for evaluation.Gross, visual, microscopic visual, tactile, dimensional and functional evaluations were performed.Under microscopic observation, multiple puncture access was noted on the port septum.Residue was noted to the port stem.The returned catheter and cath-lock were loaded to the port body for further evaluation.No loose fitting of the components was felt throughout.The port was patent to both infusion and aspiration.No leaks were observed.Therefore, the investigation is inconclusive for the reported catheter disconnection issue as the sample evaluation results indicating no issue under laboratory conditions may not be representative of the condition of the device during use.Based on the measurements recorded during sample evaluation and applicable drawings, the inner diameter of cath-lock was noted to be within the specification.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
On (b)(6) 2025, a patient underwent a port placement procedure using powerport clearvue isp implantable port, chronoflex single lumen, 8f into the right subclavian vein.Post the procedure on (b)(6) 2025, it was reported that the port body and catheter connection were allegedly found to be detached.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a port placement procedure using powerport clearvue isp implantable port, chronoflex single lumen, 8f into the right subclavian vein.Post the procedure on (b)(6) 2025, it was reported that the port body and catheter connection were allegedly found to be detached.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 power port clear vue isp implantable port, one catheter and one cath lock were returned for evaluation.Gross, visual, microscopic visual, tactile, dimensional and functional evaluations were performed.Under microscopic observation, multiple puncture access was noted on the port septum.Residue was noted to the port stem.The returned catheter and cath lock were disconnected.Tool damage was noted on the cath lock.The cath lock was not seated against the port body.Catheter lock expected to be deformed somewhat during use.Therefore, the investigation is confirmed for the reported catheter disconnection issue.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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.G3, h6 (result).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 CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23739455
• Report Number: 3006260740-2025-09387
• Device Sequence Number: 16068531
• Product Code: LJT
• UDI-Device Identifier: 00801741026409
• UDI-Public: (01)00801741026409
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

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: 1606052
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 02/23/2026; 03/24/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/24/2026; 03/26/2026
• 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