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 10/26/2022

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the medical records allege that, patient with a history of bacteremia and concern for port infection underwent removal of infected port under fluoroscopically guidance.Using a combination of sharp and blunt dissection, the catheter component of the port was localized and externalized.The fibrous tissue surrounding the port reservoir was subsequently incised and the port was removed in its entirety.The tip of the port was cut and sent to pathology for further evaluation.After two days of sampling port-a-cath tip culture report showed positive for methicillin resistance staphylococcus aureus.After nine days later patient underwent placement of port for recurrent urinary tract infection and venous access is required for long term antibiotics.A subcutaneous tunnel was created to the left anterior chest wall and through incision left chest and a subcutaneous pocket was created.And the port and catheter placed in the pocket, under fluoroscopic guidance was positioned with the catheter tip in the right atrium.Approximately two years seven months later, patient presented to the emergency department for concern for infection of port-a-cath.Patient had an infected line when it was on the right but his current power port on the left.Patient had rash on chest.After medication by the doctor patient went to home.Chest x-ray was performed which showed left sided chest port is seen with its tip over the right atrium.One month twenty seven days later patient presented for portogram procedure to eval the port-a-cath.The study showed normal port-a-cath venogram, good aspiration and injection.After four months twenty nine days of study patient underwent port removal procedure for port site infection.The port and catheter were removed in entirety.Around one day later central line tip catheter culture report showed positive for methicillin resistance staphylococcus aureus.After twenty days of culture report patient underwent port placement procedure for chronic infection with ultrasound and fluoroscopy guidance.An incision was made over the chest wall, a pocket was created, and the catheter was tunneled subcutaneously to the venous access site and trimmed to appropriate length.The port was inserted into the pocket and the catheter was advanced via a peel away sheath into the vein under fluoroscopic guidance.Fluoroscopy confirmed with tip at the junction of superior vena cava and right atrium.Then ten months twenty-five days later urine culture report showed positive for escherichia coli.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 stroke.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 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 ten months and three days post a port placement, the patient was allegedly diagnosed with bacterial infection urine culture report showed positive for escherichia coli.It was further reported that the patient allegedly experienced stroke.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: 19049507
• MDR Text Key: 339464047
• Report Number: 3006260740-2024-01492
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

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: 03/25/2024
• Initial Date FDA Received: 04/05/2024
• 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): Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male