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

Catalog Number 1808061

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

Patient Problems Unspecified Infection (1930); Fungal Infection (2419)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported through the litigation process that seven months sixteen days post port placement for administration of total parenteral nutrition in treatment of gastroparesis, the patient was diagnosed with infection.However, the current status of the patent is unknown.

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.

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 (expiration date: 06/2022).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 six months and twenty-nine days post a port placement via the left internal jugular vein in the atriocaval junction, the patient allegedly developed with candida albicans fungal infection as a result of the defective infected catheter.Reportedly, the entire port and catheter were removed intact.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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.Medical records were provided and reviewed.The medical record states that implanted port was placed in a patient after diagnosis of severe gastroparesis and the fluoroscopy confirmed the port placement.Approximately after twelve months later, blood culture shows the positivity sign of gram-positive cocci staph infection not staph aureus and the patient allegedly developed with bacteremia as a result of the defective infected catheter.Three days later, removal of right chest port-a-cath was undertaken due to the clinical indication bacteremia.The removal of port and catheter was taken placed by removing the port from the port pocket under the skin and the catheter tubing was also removed intact.After approximately seven months later, another bard implantable port placement was made by implanting the port at the atriocaval junction with the help of fluoroscopic guidance through the left internal jugular vein approach.The placed port was aspirated and flushed with heparinized saline.Approximately after another seven months later, port removal was undertaken due to infection, and the inserted port and catheter was removed completely.A month later through the right internal jugular vein approach, another bard implantable port was placed in the atriocaval junction without any difficulty for a patient after being diagnosed with severe gastroparesis.The port was aspirated and flushed with heparinized saline.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 developed fungal infection.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.H10: d4 (expiration date: 06/2022).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 six months and twenty-nine days post a port placement via the left internal jugular vein in the atriocaval junction, the patient allegedly developed with candida albicans fungal infection as a result of the defective infected catheter.Reportedly, the entire port and catheter were removed intact.The current status of the patient is unknown.

• Brand Name: POWERPORT ISP M.R.I. 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: 17593803
• MDR Text Key: 321620372
• Report Number: 3006260740-2023-03600
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027048
• UDI-Public: (01)00801741027048
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: 1808061
• Device Lot Number: REEW1079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 03/12/2024; 04/25/2024
• Supplement Dates FDA Received: 04/08/2024; 04/30/2024
• 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: 27 YR
• Patient Sex: Female