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 5608062

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

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

Event Date 07/04/2022

Event Type  Injury  

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: 05/2021).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 two years, one month, and two days post a port placement in the superior vena cava right atrial junction via the right subclavian vein, the patient allegedly developed with gram-positive cocci staphylococcus aureus bacterial infection.It was further reported that the patient allegedly developed with sepsis secondary to bacterial infection as a result of the defective infected port.Reportedly, the infected port and catheter were removed intact.The current status of the patient is unknown.

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.Medical record was provided for review.Medical record alleges that bard implant port was placed for a patient for being diagnosed with the lymphoma at the level of left subclavian vein and the procedure was went well.Approximately 10 months and 27 days later of the port placement your fluoroscopic study was performed which revealed that the blood was allegedly unable to withdraw and it was further reported that the patient allegedly experience with the thrombin sheet formation on the catheter and the tip of the catheter in the superior vena cava, there was no crack or kink on the catheter.Approximately 4 months later the left subclavian port has been removed and through the right subclavian vein approach and another part power port was implanted in the superior vena cava write a drill junction for the same diagnosing of lymphoma the procedure went well.Approximately 2 years and month later the patient allegedly developed with the gram positive cocci due to the staphylococcus areas bacterial infection and further the patient allegedly developed with the sepsis secondary to the bacterial infection as a result of defective infected port.The removal of right subclavian port was performed and the port was freed up from the subcutaneous tissue tubing was removed the port intact and the infected port and catheter was removed.Therefore, it can be confirmed that the patient experienced bacterial infection and sepsis.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 (expiry date: 05/2021), g3, h6 (method).H11: h6 (result, conclusion).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 two years, one month, and two days post a port placement in the superior vena cava right atrial junction via the right subclavian vein, the patient allegedly developed with gram-positive cocci staphylococcus aureus bacterial infection.It was further reported that the patient allegedly developed with sepsis secondary to bacterial infection as a result of the defective infected port.Reportedly, the infected port and catheter were removed intact.The current status of the patient is unknown.

• 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: 19123575
• MDR Text Key: 340336294
• Report Number: 3006260740-2024-01831
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122899
• 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: 05/21/2024

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: 5608062
• Device Lot Number: REEP4327
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2020
• 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
• Patient Age: 65 YR
• Patient Sex: Female