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

Catalog Number 1708160

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

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 03/28/2022

Event Type  Injury  

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.

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 were 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 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 approximately four months and twenty days post a port placement via the right internal jugular vein, the patient allegedly developed serratia marcescens bacteremia and was diagnosed with sepsis.Reportedly, the device was removed from the patient.However, the current status of the patient is unknown.

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 placement of bard port was performed for a patient.Using real- time ultrasound guidance the right internal jugular vein was accessed and a peel-away sheath was placed.A subcutaneous pocket was then created using blunt dissection.A powerport was flushed with normal saline.The port was placed within the pocket and the catheter was then advanced under fluoroscopic guidance through the peel-away sheath to the right atrium.The catheter was attached firmly to the port.The port was accessed and aspirated freely.Saline injection was then performed and there was no leakage.The incision was closed.The port was then flushed with heparin and may be used immediately.Approximately four months later the patient was hospitalized four days for serratia marcescens bacteremia with urinary tract or suspected primary source and was treated for the same.After fourteen days due to return of serratia bacteremia it was concerned that the port was infected.The patient had a principle diagnosis of sepsis and infection due to port-a-cath.On the same date, blood culture specimen was collected.Two days later the culture results received, showed serratia marcescens which is known to possess an inducible beta-lactamase.The patient was asked to be monitored for resistance after using cephalosporins or extended spectrum penicillin.On the same day, port removal was performed due to bacteremia.Skin incision was made over the patient¿s prior incision, and combination of sharp and blunt dissection were carried down to the patient¿s port.The catheter was clamped and fibrin sheath surrounding the port was incised and dissected free from the port.Port and catheter were then removed intact.The pocket was copiously flushed with normal saline solution.Hemostasis was confirmed by inspection of the pocket.The port pocket was closed with sutures.There were no immediate complications and the patient tolerated the procedure well.Post procedure imaging demonstrated no retained catheter fragment.Successful right chest single lumen port removal.Therefore, it can be confirmed that the patient experienced infection and 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.H10: b2, d4 (expiry date: 06/2023), g2, g3, h6 (method).H11: b3, b5, d4 (medical device lot number), h6 (patient, result).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.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 19086023
• MDR Text Key: 339877535
• Report Number: 3006260740-2024-01629
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072215
• 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: 05/10/2024

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: 1708160
• Device Lot Number: REFV2421
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female