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

Catalog Number 5608062

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

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

Event Date 05/27/2023

Event Type  Injury  

Event Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced infection.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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.

Manufacturer Narrative

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 physical device was not returned for evaluation.The medical records allege that, a patient underwent port-a-cath insertion procedure for treatment for malignant neoplasm of upper outer quadrant of left breast.And the port placement proceeded as skin incision on the chest wall and a subcutaneous tunnel, pocket were then constructed using blunt dissection.The chest power port catheter was tunneled from the chest wall incision to the cervical incision.A peel away sheath was then advance over the guidewire into the superior vena cava.The chest port catheter was then advanced through the peel away sheath using fluoroscopic guidance into the superior vena cava.The catheter was positioned with its tip at the junction of the superior vena cava and right atrium and cut to length.Further the chest power port catheter was attached to the chest port reservoir.And the port catheter was flushed and ready for use.Approximately four months twenty-six later the port placement, patient admitted from emergency department for evaluation of muscle spasm and puss drainage from the port-a-cath of right chest wall.Patient diagnosed with unspecified infection due to central venous catheter.After two days the patient discharged.After two days, patient underwent port-a-cath check and port-removal procedure for cellulitis of the chest wall.A single incision was made over the reservoir and port was removed in its entirety.Post-procedural image demonstrated no residual catheter fragments within the chest.The incision was sutured using interrupted subcutaneous sutures.Therefore, the investigation is confirmed for the reported infection based on the medical records.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.(expiration date: 11/2023) 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.

Event Description

It was reported through the litigation process that four months and fourteen days post a port placement via the right internal jugular vein, the patient allegedly developed with staphylococcus aureus bacterial infection as a result of the defective infected port.Reportedly, the infected port was removed.The current status of the patient is unknown.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 19085892
• MDR Text Key: 339877858
• Report Number: 3006260740-2024-01622
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027369
• UDI-Public: (01)00801741027369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: 5608062
• Device Lot Number: REGT5424
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/08/2024
• 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: 40 YR
• Patient Sex: Female