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

Catalog Number	A710962
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No medical records were provided for review.Therefore, the investigation is inconclusive for the reported infection as no objective evidence was provided for review.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.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.
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the patient developed with unspecified infection.The current status of the patient was unknown.
Event or Problem Description
It was reported through litigation process that on (b)(6), 2020, the patient underwent a lateral right internal jugular vein chest port-a-cath placement procedure using a powerport for long term central venous access for intermittent apheresis as part of myasthenia gravis treatment.After some time later, the patient developed with unspecified infection.Subsequently, the port was removed.However, the current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the physical device was not returned for evaluation.No medical records were provided for review.Medical record alleges that, the patient underwent an implantable port placement procedure using a powerport for long term central venous access for intermittent apheresis as part of myasthenia gravis treatment, the patient had two bard powerflow implantable apheresis iv port implanted laterally and medially.Approximately one year, eight months and six days later, the patient was performed with blood culture.It was reported with staphylococcus capitis (a).Approximately eight days later, the patient with indication of bacteremia was planned for lateral right internal jugular vein chest port a cath removal.The catheter leading to the jugular vein was completely removed.The port pocket demonstrated no signs of infection.Next day, the patient with indication of infection from unknown source underwent a medial right chest port removal.The port and catheter were removed in their entirety.Therefore, the investigation is confirmed for the reported infection.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 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.B5, d4 (medical device lot #, unique identifier (udi) #), g3, h6 (method, result) 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: APHERESIS PORT
• 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 ; 4803032689
• MDR Report Key: 22305122
• Report Number: 3006260740-2025-04141
• Device Sequence Number: 15452974
• Product Code: PTD
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K163001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: A710962
• Device Lot Number: REEN3569
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2020
• 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: 59 YR
• Patient Sex: Male