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

Catalog Number	5668362
Medical Device Problem Codes	Reflux within Device (1522); Air/Gas in Device (4062)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a port placement procedure using the powerport clearvue isp implantable port.Post procedure, during the first attempted access for chemotherapy infusion, needle insertion resulted in aspiration of clear fluid instead of blood return.The clinician noted a bubble of fluid surrounding the port site.Although the fluid was drained, it repeatedly reaccumulated.Due to the persistent fluid and the inability to administer chemotherapy through the port, the physician determined that port removal was necessary.There were no signs of infection, and analysis of the aspirated fluid confirmed it was non infectious.It was further reported that the patient experienced pain.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 on (b)(6) 2025 using the powerport clearvue isp implantable port.Post procedure, during the first attempted access for chemotherapy infusion, needle insertion resulted in aspiration of clear fluid instead of blood return.The clinician noted a bubble of fluid surrounding the port site.Although the fluid was drained, it repeatedly reaccumulated.Due to the persistent fluid and the inability to administer chemotherapy through the port, the physician determined that port removal was necessary.There were no signs of infection, and analysis of the aspirated fluid confirmed it was non-infectious.It was further reported that the patient experienced pain.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport clearvue isp implantable port was returned for sample evaluation.Visual evaluation, microscopic visual observation and functional testing were performed.Gross examination of the port body showed multiple puncture access was observed on the port septum.No other anomalies were noted.Therefore, the investigation is unconfirmed for the reported backflow and air in device issues.A definitive root cause could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (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.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX, 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: 24301040
• Report Number: 3006260740-2026-00660
• Device Sequence Number: 15872805
• Product Code: LJT
• UDI-Device Identifier: 00801741110757
• UDI-Public: (01)00801741110757(17)270430(10)REKU2650
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 5668362
• Device Lot Number: REKU2650
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White