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

Catalog Number	5616000
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a port placement procedure using the powerport clearvue slim.During the procedure it was noted that rings present on the catheter that prevented it from being used as intended.As a result, the port could not be implanted.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 is currently being 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 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
H11: additional information was received through the follow up and the file was reassessed for reportability.Based on the updated information the patient experienced bleeding and therefore, the case determined to be a serious injury.Manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 6.5fr peel apart sheath and vessel dilator were returned for evaluation and two photos were provided for review.The photo shows the sheath in which vessel dilator was inserted.Bent and bunching was noted on the sheath.Gross, visual and functional evaluations were performed on the returned device.The device was noted to be bent.Bunching was noted on the distal portion of the sheath shaft.An attempt to remove the vessel dilator from the peel apart sheath was performed and retracted with no resistance.An attempt to loaded back the vessel dilator to the peel apart sheath was performed and was successful.Therefore, the investigation is confirmed for the reported rings present on sheath issue (bunching).However, the investigation is inconclusive for the reported failure to advance issues as the exact circumstance at the time of the reported event cannot be verified from the received sample.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.B1, b2, b5, d4 (unique identifier (udi) #), g3, h1, h6 (patient, device, component, method, result, conclusion) 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
On (b)(6) 2026, a patient underwent a port placement procedure using the powerport clearvue slim.During the procedure, rings were observed on the airguard introducer that interfered with insertion and prevented the device from being used as intended.As a result, the port could not be implanted.And also, patient experienced bleeding.The current status of patient is fine.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
• 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: 24219574
• Report Number: 3006260740-2026-00330
• Device Sequence Number: 9238188
• Product Code: LJT
• UDI-Device Identifier: 00801741027376
• UDI-Public: (01)00801741027376(11)250424(17)261130(10)REKP0998
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 5616000
• Device Lot Number: REKP0998
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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