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

Catalog Number 1808000

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

Patient Problems Chest Pain (1776); Erythema (1840); Unspecified Infection (1930)

Event Date 07/03/2022

Event Type  Injury  

Event Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly developed infection.However, 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 medical record was 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.

Event Description

It was reported through the litigation process that one year, one month and twenty-one days post a port placement via the left subclavian vein, the patient allegedly experienced left chest wall pain and erythema.It was further reported that the patient allegedly developed infection.Reportedly, the port was removed from the patient.However, 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.Medical record was provided for review.The medical records allege that, a patient had history of asthma, crohn's disease, hypertension, lower gastrointestinal bleed, and pulmonary embolism underwent to the mediport placement to requiring frequent iv access for therapies.A pocket was created inferior to the entrance site of the wire.Subcutaneous pocket was established.A power flow port was utilized.This was advanced through the subcutaneous tissue to the entrance site of the wire.Over the wire, dilator and sheath were advanced, the wire and dilator were removed through the sheath and the catheter was placed.Again, under fluoroscopy, this appeared to be in adequate position.Catheter was flushed and had good blood return.It was flushed with heparinized saline.The mediport was anchored in the subcutaneous tissue.Approximately one year one month and twenty-one days post port implantation the patient had left sided chest wall pain and tenderness.The port site was red with mild erythema and tenderness over the port site.Then the next day left chest was prepped and draped in sterile fashion.His previous incision opened, the port removed, hemostasis was secured.The wound was closed.There was 2 ml of pus expressed.The wound was otherwise clean.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 infection, chest wall pain and erythema.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.

• Brand Name: POWERPORT 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: 19001933
• MDR Text Key: 338876253
• Report Number: 3006260740-2024-01353
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741000430
• UDI-Public: (01)00801741000430
• 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: Other,Consumer,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: 1808000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 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: 39 YR
• Patient Sex: Male