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

Catalog Number 1608062

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067)

Event Date 03/03/2022

Event Type  Injury  

Event Description

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

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date:11/2022).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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that one week and six days post a port placement via the right internal jugular vein, the patient was allegedly diagnosed with sepsis.It was further reported that the blood culture test confirmed the patient was allegedly developed with methicillin-sensitive staphylococcus aureus bacteremia which was attributed to a port infection.Furthermore, the patient was treated with intravenous antibiotics.Reportedly, the infected port was surgically removed from the patient.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 device was not returned for evaluation.Medical records were provided.The medical review states that placement of single lumen port was performed via right internal jugular.The catheter was attached to the port reservoir and cut to length.The catheter was advanced through the subcutaneous tunnel and the reservoir was placed in the pocket by making an incision.Under fluoroscopic guidance, a peel away sheath was placed and the catheter was advanced and placed the catheter tip within the right atrium.The line flushed and aspirated appropriately.Four days later positron emission tomography/computed tomography showed a tip terminating in the cavoatrial junction was noted.After a month later, removal of the port was performed due to bacteremia.No gross sign of infections were found.The port pocket was irrigated and hemostatic.The subcutaneous pocket previously containing the port was closed.The tip was sent for culture.Therefore, the investigation is inconclusive as no objective evidence for the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced bacteremia.However, the relationship to the port is unknown.Furthermore, the clinical condition alleged in the complaint cannot be confirmed.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: 11/2022).H11: b3, b5, h6 (patient, result, conclusion).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.H3 other text: device not returned.

• Brand Name: POWERPORT CLEARVUE ISP 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: 19072861
• MDR Text Key: 339777867
• Report Number: 3006260740-2024-01592
• 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,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 1608062
• Device Lot Number: REFT0862
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male