MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PowerPort Implantable Port, Groshong Single-Lumen, Kit, 8F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	1778000
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Suction Problem (2170); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.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
It was reported through litigation process that sometime later port placement procedure, the catheter fractured.However, the current status of the patient is unknown.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2013, a patient underwent the port placement procedure via the right internal jugular for intravenous peripheral access of an unknown condition.Approximately six years and ten days later, on arch (b)(6) 2019, the blood could not be drawn from the port.Additionally, twenty-nine days later, on (b)(6) 2019, the catheter had allegedly fractured and the fragment had migrated to supraclavicular soft tissue and to the upper superior vena cava.Subsequently, the port was removed on the same day, and a new catheter was implanted.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: additional information was identified in medical record review.Upon review of the additional information, the file was reassessed for reportability.Fractured fragment migration to supraclavicular soft tissue and to the upper superior vena cava, and foreign body in patient is determined to be reportable as serious injury, and hence the event type was changed to serious injury.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: although the physical device was not returned for evaluation, medical records were provided for review.Medical records allege that, the plaintiff was implanted with powerport implantable port via right internal jugular vein under ultrasound guidance for iv peripheral access.Approximately, six years and ten days later, during the blood draw, the physician had trouble in drawing the blood from port.So, a portogram was performed which revealed that the chest port catheter that had fractured and the two fragments from the fractured catheter had moved to soft tissues of the right side of the neck and to right internal jugular vein and upper svc.Further, chest x ray was performed after four weeks and one day later which showed same results.Subsequently, the catheter was removed on the same day, but the fragments could not be retrieved, and a new catheter was implanted.Therefore, the investigation is confirmed for the reported suction issue, catheter fracture, material separation, migration and retained catheter fragments in the patient's body issues.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B1, b3, b5, g3, h1, h6 (patient, device, method, result).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 Implantable Port, Groshong Single-Lumen, Kit, 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: 21280746
• Report Number: 3006260740-2025-00214
• Device Sequence Number: 7892679
• Product Code: LJT
• UDI-Device Identifier: 00801741026874
• UDI-Public: (01)00801741026874(10)REVF0043
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K081311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: 1778000
• Device Lot Number: REVF0043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 09/28/2026
• 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 Age: 45 YR
• Patient Sex: Female