MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1859660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Septic Shock (2068); Bacteremia (4846)
Date of Event	04/09/2024
Type of Reportable Event	Death
Additional 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: 01/2024) 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.
Event or Problem Description
It was reported through litigation process that approximately nine months twenty-eight days later post port placement procedure for intravenous access, the patient allegedly diagnosed with bacteremia.It was further reported that patient developed sepsis and septic shock and was treated with antibiotics.However, the patient was expired and the cause of death was septic shock and methicillin resistant staphylococcus aureus bacteremia.
Additional 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.The medical records report that over 9 months after port placement, the patient reported left side back pain that radiated down the left leg.Patient was found to have fever of unknown origin and was diagnosed with severe sepsis secondary to mrsa bacteremia.He was started on intravenous vancomycin with loading dose.Chest x-ray was performed for history of sepsis.The study showed left sided port-a-cath remains.Patient experienced brief svt and had moderate pericardial effusion.Code blue called for pea noted on cardiac monitor.Patient was blue in color, apneic, chest compressions were initiated, and acls was started.Heart rate returned to low 100 and family was notified of code event and successful resuscitation.On (b)(6) 2024, the intensivist met with family for meeting and the family decided upon withdrawal of care.Patient was expired due to septic shock and mrsa bacteremia.Therefore, it can be confirmed that the patient experienced bacteremia, sepsis, septic shock, and expired.However, the relationship to the port is unknown.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: g3, h6 (method).H11: d4 (unique identifier (udi) #), h6 (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.
Event or Problem Description
It was reported through litigation process that nine months and twenty eight days post a port placement for intravenous access, the patient allegedly diagnosed with bacteremia.It was further reported that patient developed sepsis and septic shock and was treated with antibiotics.However, the patient was expired and the cause of death was septic shock and methicillin resistant staphylococcus aureus bacteremia.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F
• Common Device Name: 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: 20134001
• Report Number: 3006260740-2024-04925
• Device Sequence Number: 7446998
• Product Code: LJT
• UDI-Device Identifier: 00801741027222
• UDI-Public: (01)00801741027222(11)221221(17)240131(10)REGY2369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 1859660
• Device Lot Number: REGY2369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White