MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1806061

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

Patient Problems Bacterial Infection (1735); Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Sepsis (2067)

Event Date 05/01/2022

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.H3 other text : device not returned.

Event Description

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

Event Description

It was reported through litigation process that approximately three months and five days post a port placement via the right internal jugular vein, the patient allegedly experienced redness and pain over the port.It was further reported that the patient allegedly developed bacterial infection with the blood culture resulted positive for methicillin-susceptible staphylococcus aureus bacteria and was diagnosed with staphylococcus aureus bacteremia associated with the port infection.Furthermore, the patient allegedly developed cellulitis and sepsis due to the infected port.Reportedly, patient was treated with antibiotics and the infected port was removed.However, the current status of the patient 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 alleged that bard power port was implanted for the treatment of malignant neoplasm to the left breast.The placement procedure was taken place by using an ultrasound guidance and the needle was access into the right internal jugular vein where the wire was made over into the inferior vena cava, your flow switch device was placed on the dilator and the site on the right upper chest which has been anesthetized and dermatotomy was made to accommodate the port.A port packet was created by using a blunt dissection in the subcutaneous tissue and the catheter was connected to the tunneling device from the port packet to the internal juggler puncher site, the catheter was pulled through the tunnel and the inner dilator and the wire were then removed, the catheter was inserted into the pillowy sheet where the proximal end of the catheter was cut to the length and fits to the port then the peel away sheet was removed and the port was positioned in the packet.After the placement of port it was flushed and aspirated easily.Approximately 5 months later the patient had a compliance of redness and pain over the mediport and infection, the preliminary analysis of the blood culture shows the mssa bacteremia and with the sign of sepsis with ongoing fever due to the staphylococcus aureus bacteremia associated with the right chest port infection.Further the patient was diagnosed with the infection due to the port, sepsis, cellulitis.On the same day the surgeon consulted for the infected port, upon accessing the port there was noted to be some purulent drainage inflammatory changes in the subcutaneous soft tissue adjacent to the right upper chest port with minimal skin thickening may represents cellulitis.The further study should add ,bubbles to the adjacent side of the port may be related to the infection versus related to introduction of the air by the recent access to the port.Within the same day the port removal procedure was conducted for the infected port and the removal procedure carried out by making an insertion over the capsule of the port packet and the pressure was then placed over the internal jugular vein where the catheter was inserted.The line was then removed with the tip intact the port and the catheter was removed and sent for culture further the wound was closed and the insertion was packed with the iodoform.On the missed day the patient was seen by the infectious disease consultation of the port and the bacteremia later the patient was discharged on iv ancef to complete the course of six weeks.Therefore, it can be confirmed that the patient experienced bacterial infection, bacteremia ,sepsis, cellulitis and pain.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: 12/2022), g2, g3, h6 (method).H11: b3, b5, d4 (medical device lot number), h6 (patient, result).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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX
• 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: 19113800
• MDR Text Key: 340227381
• Report Number: 3006260740-2024-01775
• Device Sequence Number: 1
• Product Code: LJT
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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: 1806061
• Device Lot Number: REFQ3635
• 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: 05/29/2024
• 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; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 61 KG