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

Catalog Number	1808002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bacterial Infection (1735); Sepsis (2067); Neck Pain (2433); Thrombosis/Thrombus (4440); Bacteremia (4846)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that approximately two months and fourteen days post a port placement, the patient allegedly developed with neck pain and thrombosis.It was further reported that patient was developed with bacteremia, bacterial infection and sepsis.Reportedly, the port was removed and new port has been implanted.However, the current status of the patient was unknown.
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: (expiry date: 04/2023).H11: section a through f - the information provided by bd represents all of 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
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Medical records alleged that the patient underwent port placement procedure for treatment for esophageal cancer.Placement procedure was completed, and port was flushed with heparinized saline.Approximately two months fourteen days later patient presented to the emergency department with the complaints of headache, right sided neck pain, generalized weakness and fatigue.He reports chronic neck pain but has worsened over last week.The same day blood culture showed positive for infection and confirmed as prevotella after three days.He was found to have multi organism bacteremia/sepsis without shock.He was completed a course of zosyn, meropenem and vancomycin.He was clinically improved.Approximately two days after the hospital visit chest x-ray was performed which showed left medi port catheter was again noted.Approximately after three days of x- ray patient with streptococcal sepsis with port in place.Again x- ray chest was performed after three days which showed left sided medi port terminates in the lower superior vena cava.Approximately two days post x ray patient underwent port removal procedure for port infection.Surgical pathology study of left chest port was performed after three days showed that the port attached with white catheter and measurement was captured.Tip was smooth and no tissue was submitted.Approximately after three days later patient underwent bilateral upper extremities doppler study for pain and shortness of breath.The study showed bilateral superficial venous thrombosis affecting the right and left sided basilic vein.Approximately after eight days later patient with strep bacteremia and was continued on meropenem.Therefore, the investigation is inconclusive for the reported catheter fracture as no objective evidence was noted in medical records.Furthermore, clinical conditions alleged in the complaint can be confirmed.Based upon available information, the definitive root cause was 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: 04/2023), g3, h6 (method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).
Event or Problem Description
It was reported through litigation process that approximately two months and fourteen days post a port placement, the patient allegedly developed with neck pain and thrombosis.It was further reported that patient was developed with bacteremia, bacterial infection and sepsis.Reportedly, the port was removed, and new port has been implanted.However, the current status of the patient was unknown.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 20062888
• Report Number: 3006260740-2024-04725
• Device Sequence Number: 12718047
• Product Code: LJT
• UDI-Device Identifier: 00801741026997
• UDI-Public: (01)00801741026997(17)230430(10)REFT1486
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1808002
• Device Lot Number: REFT1486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American