MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNKNOWN POWER PORT

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

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2022

Event Type  Death  

Manufacturer Narrative

H10: date of death for this patient was not provided, date of death updated as 01-jan-1900 for the mdr submission requirement.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.

Event Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced unspecified infection.It was further reported that the patient allegedly developed with sepsis as a result of the defective infected port.Furthermore, the patient reportedly expired.Reportedly, there was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

Manufacturer Narrative

Previously reported: the manufacturer received information alleging the device backup battery did not kick on and the device died.The manufacturer received information alleging the patient passed away while on the device.The dme did a download and did not see any data from the day the patient passed away.Medical intervention not reported.During the evaluation of the device at the manufacturer's product investigation lab, they were unable to confirm the complaint of the device allegedly not activating and the device not alarming.The devices error log was downloaded and reviewed, and found that the device was not in use at the time of the event in question.The device was manually turned off on 07/03/2023 and not turned back on until 09/27/2023.The device was tested and passed all relevant test steps.The device operated and alarmed as it should.

Event Description

It was reported through the litigation process that one year, eight months and thirteen days post a port placement via the left subclavian vein, the patient allegedly experienced bleeding from the port site.It was further reported that the patient allegedly developed with bacterial infection with the culture resulted in moderate bacillus species with moderate staphylococcus.Furthermore, the patient was diagnosed with gram-negative bacteremia and sepsis as a result of the defective infected port.Reportedly, the patient expired and the cause of death was immune effector cell associated neurotoxicity syndrome and relapsed pre-b cell acute lymphoblastic leukemia.However, there was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.

• Brand Name: UNKNOWN POWER PORT
• 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: 18694214
• MDR Text Key: 335195997
• Report Number: 3006260740-2024-00492
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 04/04/2024

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: UNKNOWN POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/15/2024
• 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): Death
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Race: Black Or African American