MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1708000

Device Problems Fluid/Blood Leak (1250); Difficult to Flush (1251); Suction Problem (2170); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

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.H10: d4 (expiry date: 04/2023).H11: 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 Description

It was reported that sometime post a port placement, the port was allegedly difficult to flush.It was further reported that the device allegedly could not get a blood return.There was no reported patient injury.

Event Description

It was initially reported that post port placement procedure sometime in (b)(6) 2023, the device allegedly had a suction issue and was difficult to flush; however, after flushing and using heparin, the port was able to be used without impact to the patient.It was also reported that this port was used two times a day, seven days a week and the port flushed as expected every time since this initial event.It was later identified during a follow up phone call that approximately one month after the initial event was reported, that same port was blocked up again and the patient visited the er.During the er visit, attempts were made to get the port going again but were unsuccessful.Sometime post er visit (exact date not known), a general surgeon and a radiologist conducted an x-ray of the port with contrast and identified that the port was leaking.The port was removed on (b)(6) 2023 without incident and another manufacturer¿s port was placed on the other side of the patient.The patient was reported to be doing well post procedure.The device will not be returning for evaluation.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported suction issue, difficult to flush, obstruction of flow and fluid leak issues as no objective evidence was provided for review.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.H10: d4 (expiration date: 04/2023), g3, h6 (device, method).H11: 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.

• Brand Name: POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• Type of Device: 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: 18422723
• MDR Text Key: 331670469
• Report Number: 3006260740-2023-05954
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026577
• UDI-Public: (01)00801741026577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1708000
• Device Lot Number: REFV1198
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/30/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female