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

Catalog Number UNKNOWN PORT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067)

Event Date 05/11/2022

Event Type  Injury  

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 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 Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced unspecified infection.It was further reported that the patient allegedly developed with sepsis as a result of the defective infected port.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records received and reviewed.The medical records allege that a porta-a-catheter was implanted to a patient who's having history of multiple myeloma.The port implantation process procedure underwent by threading a removable sheet in the superior vena cava and the catheter was placed in the port packet and then the peel away sheet was removed.Then the catheter was attached to the reservoir and the blood was aspirated through it further the catheter was flushed with happen nice saline solution.Further the reservoir was switch third to the anterior chest wall.The cavity was then copiously irrigated with antibiotic solution.Approximately 7 years and four months later of post port implantation during an appointment the port was flushed, and the patient was discharged shortly after the patient become diaphoretic with chill and presented to the emergency room.The patient had a headache which was improved with medication after four days later.In the emergency department the patient found to be fibral to 103, tachycardic and slightly hypertensive hands it was started on a broad-spectrum antibiotic and has defervesced ever since.The er department was consulted and given a concern for port infection given temporal relationship between accessing port after a very long time and on set symptoms suggestive of sepsis.Two days later there was no obvious concern for port infection based on the examination.After approximately a week the port removal procedure was take place by flashing the right-side subclavian vein of the chemotherapy port blood culture was positive for stenotrophomonas.With the small insertion made superior to the original insertion site using a combination of blend and sharp dissection the chemo port reservoir and the associated catheter well directly visualized.Then the catheter was secured using a code hemostat and both port and catheter were removed intact through the incision.The tip of the catheter was cut placed in a specimen container and sent to microbiology lab for culture studies.The subcutaneous packet was irrigated, and the port packet was closed.Post procedural digital fluoroscopic imaging was obtained which demonstrated complete removal of chemo port reservoir and the associated catheter it was technically successful of removal of right subclavian chemotherapy port and catheter tip was sent to microbiological studies.Therefore, the investigation is inconclusive as no objective evidence for the the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced bacterial infection and sepsis.However, the relationship to the port is unknown.Furthermore, the clinical condition 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.H11: 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 Description

It was reported through the litigation process that seven years, four months and twenty days post a port placement, the patient allegedly experienced stenotrophornonas infection.It was further reported that the patient allegedly developed with sepsis as a result of the defective infected port and the port was removed.The current status of the patient is unknown.

• Brand Name: UNKNOWN PORT
• 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: 18693507
• MDR Text Key: 335186931
• Report Number: 3006260740-2024-00483
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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: UNKNOWN PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 46 YR
• Patient Sex: Male
• Patient Race: Black Or African American