MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 Vaccess CT Power-Injectable Implantable Port, ChronoFlex, 6F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	7380000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067); Bacteremia (4846)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime post port placement procedure, the patient allegedly developed infection.However, the current status of the patient is unknown.
Additional 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 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 the litigation process that, on (b)(6) 2022, a patient underwent the port placement procedure via the right internal jugular vein for chemotherapy of laryngeal carcinoma.Approximately, five months and twelve days later, on (b)(6) 2022, the patient was diagnosed with bacteremia which was confirmed through blood cultures.Additionally, patient was diagnosed with unspecified infection.Subsequently, the port was removed on (b)(6) 2022.Further, four days later, on (b)(6)2022, patient was diagnosed with vancomycin resistant enterococcal bacterial infection and sepsis due to serratia septicemia.However, the current status of the patient remains unknown.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2022, a patient underwent the port placement procedure via the right internal jugular vein for chemotherapy of laryngeal carcinoma.Approximately, five months and twelve days later, on (b)(6) 2022, the patient was diagnosed with bacteremia which was confirmed through blood cultures.Additionally, patient was diagnosed with unspecified infection.Subsequently, the port was removed on (b)(6)2022.Further, four days later, on (b)(6)2022, patient was diagnosed with vancomycin resistant enterococcal bacterial infection and sepsis due to serratia septicemia.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.B3, b5, d4 (medical device lot #, unique identifier (udi) #), g3, h6 (patient, result, conclusion).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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: although the physical device was not returned for evaluation, medical records were provided for review.Medical records allege that, the plaintiff was implanted with vaccess ct low profile titanium power injectable port via the right internal jugular vein under the ultrasound guidance for iv access for chemotherapy of laryngeal carcinoma.Entire implantation procedure was done under fluoroscopy.The patient tolerated the procedure well.There were no complications.Approximately, five months and twelve days later, blood cultures were collected and found to be positive for bacteremia.Subsequently, the port was removed two days later, due to bacteremia and infected mediport and picc line was inserted.Catheter was successfully removed from the jugular vein.Subsequently, the subcutaneous reservoir was removed from the surrounding subcutaneous tissue, further, the patient came with the complaint of general weakness after four days.Blood cultures were collected and found to be positive for bacteremia, vancomycin resistant enterococcal bacterial infection, sepsis due to serratia septicemia.Therefore, it can be confirmed that the patient had experienced bacteremia, vancomycin resistant enterococcal bacterial infection, sepsis due to serratia septicemia and infected mediport.However, the relationship to the port is unknown.A review of sterilization records, endotoxin testing results, and bioburden data was conducted in accordance with applicable quality system and regulatory requirements, and no nonconformances or anomalies were identified.Based upon the provided 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.G3, h6 (method, result, conclusion) 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.

• Brand Name: Vaccess CT Power-Injectable Implantable Port, ChronoFlex, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 20279271
• Report Number: 3006260740-2024-05418
• Device Sequence Number: 7564356
• Product Code: LJT
• UDI-Device Identifier: 00801741027451
• UDI-Public: (01)00801741027451(17)221231(10)REFW5095
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 7380000
• Device Lot Number: REFW5095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided; 09/23/2026
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 09/03/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female