MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1616070
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Health Effect - Clinical Codes	Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a port placement procedure using the powerport.It was reported that during infusion, leakage was observed during drug administration.Upon inspection of the catheter, cracks were confirmed.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 device has been returned to the manufacturer for evaluation.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: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport clearvue slim implantable port attached to a catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed.Two partial circumferential breaks were noted approximately 5.8cm and 7.0cm from the distal end of the cath-lock.The edges of the first partial circumferential break were noted to be uneven.The surface was noted to be granular with residue in both regions.The edges of the second partial circumferential break were noted to be uneven.The surface was noted to be round/smooth with residue in both regions.Splits were noted on the border of both regions.Catheter wear was noted throughout the attached catheter.Upon infusion, leaks were observed from the partial circumferential breaks on the attached catheter.Therefore, the investigation is confirmed for the reported catheter fracture, fluid leak and identified catheter wear and deformation issues.Although a definitive root cause could not be determined, the fracture is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.Such kinking may have physiological, placement, usage or mechanical contributing factors.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B1, b5, d6b, e1, g3, h1, h6 (patient, device, component, method, result, conclusion).Section a through f: the information provided 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 powerport clearvue slim.It was reported that during infusion, leakage was observed during drug administration.Upon inspection of the catheter, cracks were confirmed.Reportedly, the device was removed.The current status of the patient is unknown.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 23861439
• Report Number: 3006260740-2025-09922
• Device Sequence Number: 21157021
• Product Code: LJT
• UDI-Device Identifier: 00801741026461
• UDI-Public: (01)00801741026461
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 02/05/2026

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: 1616070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown