MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 PowerPort ClearVUE Slim Implantable Port, ChronoFlex, 8F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	5678300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent port placement procedure using a powerport clearvue slim.Post the procedure on (b)(6) 2026, the patient observed a rash near the neck incision and beneath the port body incision in the areas where dressing tape had been applied.The patient reported that the rash was not associated with itching, redness, drainage, or swelling.The patient applied hydrocortisone cream and believed the reaction was caused by the dressing tape.The current status of the patient is unknown.
Event or Problem Description
On (b)(6) 2026, a patient underwent a port placement procedure using a powerport clearvue slim.Post the procedure on (b)(6) 2026, the patient observed a rash near the neck incision and beneath the port body incision in the areas where dressing tape had been applied.The patient reported that the rash was not associated with itching, redness, drainage, or swelling.The patient applied hydrocortisone cream and believed the reaction was caused by the dressing tape.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a port placement procedure using a powerport clearvue slim.Post procedure on (b)(6), 2026, the patient observed a rash near the neck incision and beneath the port body incision in the areas where dressing tape had been applied.The patient reported that the rash was not associated with itching, redness, drainage, or swelling.The patient applied hydrocortisone cream and believed the reaction was caused by the dressing tape.Current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is inconclusive for the reported rash issue as no objective evidence was provided for review.A review of sterilization records, endotoxin testing results, and bioburden data was conducted in accordance with applicable quality system and regulatory requirements, and no nonconformances or anomalies were identified.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.H.4.Device manufacture date: unknown.G3, h6 (method).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: based on the clarification received, the rash is only a local reaction and should be classified as malfunction.The file was reassessed for reportability and determined to be reportable as malfunction.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is inconclusive for the reported rash issue as no objective evidence was provided for review.A review of sterilization records, endotoxin testing results, and bioburden data was conducted in accordance with applicable quality system and regulatory requirements, and no nonconformances or anomalies were identified.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.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: as the lot number for the device was provided, a review of the device history records will be performed.The sample has not been 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) are 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.

• Brand Name: PowerPort ClearVUE Slim 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50097615
• Report Number: 3006260740-2026-05406
• Device Sequence Number: 21424779
• Product Code: LJT
• UDI-Device Identifier: 00801741110818
• UDI-Public: (01)00801741110818(17)271231(10)RELQ1432
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5678300
• Device Lot Number: RELQ1432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/14/2026; 09/22/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/08/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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