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); Stroke/CVA (1770)

Event Date 07/31/2018

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 was allegedly diagnosed with a stroke.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced bacterial infection as the tip of the port was cultured which showed positive for methicillin resistance staphylococcus aureus.It was further reported that the patient was allegedly diagnosed with bacteremia and experienced stroke.Reportedly, the infected port was removed and new port was implanted.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 were provided and reviewed.Post port placement, patient with a history of bacteremia and concern for port infection.Patient underwent removal of infected port under fluoroscopically guidance.The tip of the port was cut and sent to pathology for further evaluation.Around two days later, culture report showed positive for methicillin resistance staphylococcus aureus.Around eleven days post first port removal, patient underwent placement of port for recurrent urinary tract infection and venous access is required for long term antibiotics.After placement, under fluoroscopic guidance noted catheter tip in the right atrium.Around two years and nine months post second port placement, patient presented to the emergency department for concern for infection of port-a-cath.The port flushes well but will not draw.Chest x-ray showed left sided chest port is seen with its tip over the right atrium.Around one month and nineteen days later, patient presented for portogram procedure showed normal port-a-cath venogram, good aspiration and injection.Around four months and three days later, patient underwent port removal procedure for port site infection.The port and catheter were removed in entirety.Around two days later, central line tip catheter culture report showed positive for methicillin resistance staphylococcus aureus.Around twenty-one days later, patient underwent third port placement procedure for chronic infection.Fluoroscopy confirmed with tip at the junction of superior vena cava and right atrium.Around ten months and twenty-four days later, urine culture report showed positive for escherichia coli.Therefore, the investigation is inconclusive for the reported adverse event 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.H10: b5, g2, g3, h6 (patient, method).H11: b2, b3.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.H3 other text : device not returned.

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: d4 (expiry date: 10/2017), g3.H11: b3, b5, d1, d4, h6 (result, conclusion).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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that two years, five months and fifteen days post port placement via the right internal jugular vein, the patient allegedly experienced bacterial infection as the tip of the port was cultured which showed positive for methicillin resistance staphylococcus aureus.It was further reported that the patient was allegedly diagnosed with bacteremia and experienced stroke.Reportedly, the infected port was removed and new port was implanted.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: 18694128
• MDR Text Key: 335195303
• Report Number: 3006260740-2024-00491
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• 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: 04/22/2024

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: 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; 04/16/2024
• Supplement Dates FDA Received: 04/12/2024; 05/12/2024
• 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; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male