MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1829500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not 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 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 Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced infection.The current status of the patent is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Medical records were provided.The medical record alleges the patient underwent the bard hickman central venous catheter placement, approximately sometimes later post catheter placement the patient developed with the bacteremia and the catheter was removed.Then yeah double lumen port was placed at the right internal jugular vein for the treatment of leukocytosis where the patient had a history of lupus, mast cell activation, chronic venous access dependence with bacteremia associated with the hickman catheter that was removed hand it was now cleared that the bacteremia and the recommended port for long time access.The placement procedure was taken place by making an insertion on the skin, blend and sharp dissection was used to create the subcutaneous port packet and the catheter was advanced through the pillar way sheep in which it positioned centrally with the help of fluoroscopic guidance, then the pillowy sheet was removed hand the hemostat is was achieved with the manual compression, the catheter was cut to its appropriate glenn to reach the mid right atrium.Then the port was slide into the subcutaneous packet.The final fluoroscopy showed the port, and the catheter was to be in good position without kings and terminator at the cavoatrial junction.The lumen of the ports was then accessed with the needle for immediate use and the reservoir were instilled big, concentrated heparin in the interim.Approximately seven months later and blood culture reporter methicillin resistant staphylococcus aureus infection, five days later the patient underwent the port removal procedure for the concern of port infection with bacteremia.The removal procedure was taken with the help of local anesthetic into the right upper chest where the incision was at the optimal location for port removal with the help of blunt and sharp dissection to free the port from the packet.The port associated with the catheter were removed intact and the port cavity was inspected and found to be free from debris or blood.The procedure went well without any immediate complication.Therefore, the investigation can be confirmed that the patient experienced bacterial infection.However, the relationship to the port is unknown.Furthermore, the clinical condition alleged in the complaint cannot be confirmed.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.H10: d4 (expiration date: 12/2023), h6 (method).H11: d4 (medical device lot number), h6 (patient, result).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 through the litigation process that five months and seventeen days post a port placement via the right internal jugular vein, the patient allegedly developed with bacterial infection with the blood culture resulted growth of methicillin resistant staphylococcus aureus bacteria.Reportedly, the infected port was removed.The current status of the patent is unknown.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• 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: 19114543
• MDR Text Key: 340231036
• Report Number: 3006260740-2024-01788
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027185
• UDI-Public: (01)00801741027185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1829500
• Device Lot Number: REGW1944
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female