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	1606052
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Suction Problem (2170)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	05/13/2025
Type of Reportable Event	Serious 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 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 the low artifact power port to secure the route for blood collection.It was left for two months without flushing.On (b)(6), when blood was collected, the blood did not drain and there was swelling around the area.However, the current status of the patient was unknown.
Event or Problem Description
On (b)(6) 2025, a patient underwent a port placement procedure using the low artifact power port to secure the route for blood collection.It was left for two months without flushing.On (b)(6) , when blood was collected, the blood did not drain and there was swelling around the area.However, the current status of the patient was unknown.
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 with detached catheter and detached cath-lock were return for sample evaluations.Gross, visual, microscopic visual, tactile and functional evaluations were performed.Catheter were noted to be disconnected from port a complete diagonal break was noted on catheter.The edges break was noted to be uneven, and surface was noted to be glossy with striations.The break with striation were considered as incidental issue.Upon infusion, resistance was felt and what appeared to be thrombus, was observed exited however, aspiration was performed and was successful.No leaks were observed.As per reported issue port was no flushed in the last two month which against the instructions for use (ifu).Therefore, the investigation is confirmed for the reported disconnection and improper procedure.However, the investigation is inconclusive for the reported suction, and migration issue as provided evidence are not sufficient and exact circumstances at the time of the reported event cannot be verified from the returned physical sample.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The root cause for improper procedure issue was noted to be use error ad for other device issue could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.

• 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: 22294830
• Report Number: 3006260740-2025-04077
• Device Sequence Number: 18222483
• 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
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 11/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown