MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 7460000

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

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Sepsis (2067)

Event Date 06/16/2023

Event Type  Injury  

Event Description

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

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 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.H3 other text: device not returned.

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 record were provided for review.Medical record alleges that bard implant port was placed for a patient for the medication delivery of lupus place through the right internal jugular vein.The placement procedure was taken place by inserting a micro puncture needle into the superior vena cava through the needle lumen and then the needle was exchanged and the soft tissue of the upper chest was selected for the port placement, attract leading from the port side to the venous access site where the anesthetized with the lidocaine.Airport packet was created by using a blunt dissection and the single roman port catheter was tunneled from the port packet to the access site, the catheter was trimmed to the appropriate length and the pillowed dilator and the wire were removed, the tip of the catheter was confirmed to be at the cavoatrial junction with the help of fluoroscopy and the port was confirmed to be fleshed and drawn.Approximately two years and six months later the patient as admitted for the history of lupus undergoing lupus infusion treatment every four weeks via port in the right upper chest, yeah chronic anemia came in complaint of the right upper chest wall redness and pain and rash.Further the patient was noted to be hemodynamically stable and it was found to have the upper right chest port infection.Infectious disease consulted and started an appropriate iv antibiotics.Two days later the patient underwent the chest port removal procedure for the suspecting infected port.The right chest was prepared and an elliptical incision was made over the apache where the port was palpated near the prior scar.Then the febrile skin was removed with the overall rash, it is section was carried down through the subcutaneous tissue using electrocautery, until the port was encountered.A culture of cavity around the port was taken and the catheter was located surrounding a capsule was dissected 3 using a combination of blend dissection and the electrocautery until the cathedral was freely mobile and it was withdrawn.The remaining port was then excised from its capsule using a scalpel, the port and catheter was inspected and found to be intact the patient tolerates the procedural.Upon the post removal of port from the patient, the wound culture eventually revealed the infection of staphylococcus epidermis and the patient was translated to oral antibiotics.After two days of post removal off port the surgical pathology final report study of infected port shown.About two weeks later the patient underwent and another port placement procedure for belimumab infusion for systemic lupus erythematous, the placement procedure underwent using the ultrasound guidance a micropuncture needle was used to access the right internal jugular vein and the wire was placed to the inferior vena cava.Lidocaine with epinephrine was given from the right internal jugular side to the right anterior chest.An incision was made to the right anterior chest and the port packet was created with a blunt dissection, a torque was used to tunnel from the port packet to the right internal jugular vein dermatotomy site.The port catheter was pulled through the track and the port was placed within the port packet the catheter was cut to the appropriate size and the micro puncture sheet was exchanged over the wire for a peel away sheet.The port catheter was placed into the peelaway sheath using the fluoroscopic guidance conform the appropriate positioning of the catheter tip at the superior vena cava atrial junction for the the port was aspirated flushed and seem to be working well.After nine months later the patient was admitted with the right chest port infection and cellulitis.Your computer tomography of thorax and chest was performed and reveal the chest portion was infected with sepsis further the study showed a mild soft tissue stranding anterior to the port with overlying skin thickening is nonspecific and may represent postoperative change or an early infection or inflammatory process.That is no evidence of underlying abscess and had the placement of cefepime and doxycycline.On the same day the patient underwent port removal procedure for the localized infection where the right chest was prepared and linda caine was infused along the port side and perry catheter tract, an insertion was made over the existing scar line and the blunt dissection and traction on the port and the catheter resulted in the removal of the intact port and catheter without difficulty.The port packet was extensively irrigated and showed no sign of active infection the patient tolerate the procedural will.Again three days later the patient underwent a new port placement an implantation procedure.Therefore, it can be confirmed that the patient experienced infection, sepsis and cellulitis.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: b2, d4 (expiry date: 04/2023), g2, g3, h6 (patient, method).H11: b3, b5, d4 (medical device lot number), h6 (result).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 Description

It was reported through the litigation process that nine months and twenty-nine days post port placement via the right internal jugular vein, the patient allegedly developed with port infection.It was further reported that patient allegedly developed sepsis and cellulitis due to port infection.Reportedly, cephalosporin and tetracycline antibiotics were provided and the infected port was removed and replaced.However, the current status of the patient is unknown.

• Brand Name: VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F
• 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: 19094424
• MDR Text Key: 339984544
• Report Number: 3006260740-2024-01689
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027468
• UDI-Public: (01)00801741027468
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 7460000
• Device Lot Number: REFY2028
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/27/2024
• 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): Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female