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

Catalog Number 0607540

Device Problems Obstruction of Flow (2423); Dent in Material (2526); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Embolism/Embolus (4438)

Event Date 07/21/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiration date: 03/2021).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 sometimes, post port placement for ongoing treatment of breast cancer, the port allegedly compressed or pinched off.It was further reported that the patient allegedly developed a fever due to what was diagnosed as neutropenia and staphylococcus aureus bacteremia.Furthermore, the patient was hospitalized to declot an embolism in relation to the catheter.Reportedly, the patient underwent surgery and another procedure to remove the port.However, the current status of the patient is unknown.

Event Description

It was reported through the litigation process that sometimes, post port placement for ongoing treatment of breast cancer, the patient allegedly developed a fever due to what was diagnosed as neutropenia and staphylococcus aureus bacteremia.It was further reported that the patient was hospitalized to declot an embolism in relation to the catheter.Reportedly, the patient underwent surgery and another procedure to remove the port.However, 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 records were not provided.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.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 (expiration date: 03/2021).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.

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 device was not returned for evaluation.Medical records were provided and reviewed.Post port placement, the patient developed occlusion of the catheter.Around some days later, patient underwent removal of her port-a-catheter without any complications.Therefore, the investigation is confirmed for the reported obstruction of flow.Furthermore, the clinical conditions 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: b5, d4 (expiration date: 03/2021).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 sometimes post port placement for ongoing treatment of breast cancer, the patient allegedly developed a fever due to what was diagnosed as neutropenia and staphylococcus aureus bacteremia.It was further reported that patient was hospitalized for occlusion of the catheter and to declot an embolism in relation to the catheter and was diagnosed with staph aureus bacteremia.Reportedly, the patient underwent surgery and another procedure to remove the port.However, the current status of the patient is unknown.

• Brand Name: X-PORT 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: 17538890
• MDR Text Key: 321054211
• Report Number: 3006260740-2023-03501
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026188
• UDI-Public: (01)00801741026188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022983
• 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,Followup
• Report Date: 02/22/2024

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: 0607540
• Device Lot Number: REDZ3192
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 11/22/2023; 02/29/2024
• Supplement Dates FDA Received: 11/23/2023; 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female