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 1808060

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

Patient Problems Unspecified Infection (1930); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 11/11/2022

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 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.

Event Description

It was reported that ten months and twenty-five days post port placement via the right internal jugular vein, the patient allegedly experienced infection from the port.It was further reported that the patient allegedly developed septic embolism.Reportedly, the port was removed.The current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.Medical records were not provided.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.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.(medical device catalogue number) 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.

Event Description

It was reported that ten months and twenty-five days post port placement via the right internal jugular vein, the patient allegedly experienced infection from the port.It was further reported that the patient allegedly developed septic embolism.Reportedly, the port was removed.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that ten months and twenty-five days post port placement via the right internal jugular vein, the patient allegedly experienced infection from the port.It was further reported that the patient allegedly developed a blood clot and was diagnosed with septic embolism.Reportedly, the port was removed.The current status of the patient was 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 device was not returned for evaluation.Medical records were provided and reviewed.Approximately ten months and twenty-five days post port placement, the patient had an infected mediport.Around six days later, surgery was consulted for removal of infected mediport and placement of groshong catheter was completed.Around six months later, unfortunately left-sided groshong line also had to be removed for concerns regarding infection.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided to conform any alleged deficiency to the port.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon 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, d4 (expiry date: 08/2022).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.

• 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: 18299710
• MDR Text Key: 330113013
• Report Number: 3006260740-2023-05614
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027031
• UDI-Public: (01)00801741027031
• 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: 03/14/2024

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: 1808060
• Device Lot Number: REFT1518
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/29/2023; 03/07/2024
• Supplement Dates FDA Received: 01/10/2024; 03/25/2024
• 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: 42 YR
• Patient Sex: Male