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

Catalog Number UNK LOW ARTIFACT POWER PORT

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

Patient Problem Unspecified Infection (1930)

Event Date 06/17/2021

Event Type  Injury  

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 medical record was provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.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 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.H3 other text : device not returned.

Event Description

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

Event Description

It was reported through the litigation process that one year, one month, and nineteen days post a port placement, the patient was allegedly diagnosed with bacteremia and the blood culture test resulted positive for methicillin-resistant staphylococcus aureus bacteremia as a result of the defective infected port.Reportedly, the defective infected port and catheter were removed from the patient.The current status of the patient is unknown.

Manufacturer Narrative

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.Medical records were provided and reviewed.The medical records allege that, for a patient placement of bard clearvue single lumen chest port was performed for chemotherapy.The internal jugular vein was found to be patent and was chosen for port placement.Small incision and pocket was made for the reservoir.The catheter was tunneled to the venous access site from the pocket.The catheter placed through the peel away sheath under fluoroscopic guidance, was trimmed to appropriated length and connected to the reservoir.The reservoir was placed into the pocket.The port was accessed and demonstrated good blood draw and flush.The port was ready for use.The patient tolerated the procedure well and there were no immediate complications.After one year one months sixteen days the patient was admitted to the hospital and was diagnosed with sepsis/bacteremia.A blood culture was performed which noted methicillin-resistant staphylococcus aureus, including from chemo port.Around five days later removal of chest port was planned as the patient was bacteremia with concern for superinfection of the port.Small incision was made over the pre-existing port reservoir.Using both blunt and sharp dissection, the port and the catheter were removed.The pocket was irrigated with normal saline.The port pocket was closed.Spot fluoroscopic images demonstrated complete removal of the chest port without any retained foreign body.The patient tolerated the procedure well and there were no immediate complications.Catheter tip was sent for culture.Therefore, the investigation is inconclusive as no objective evidence for the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced bacteremia.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.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.

• Brand Name: LOW ARTIFACT POWER 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: 19072301
• MDR Text Key: 339774108
• Report Number: 3006260740-2024-01589
• 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,Followup
• Report Date: 04/25/2024

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: UNK LOW ARTIFACT POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/14/2024
• 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: 70 YR
• Patient Sex: Male