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

Catalog Number 5608062

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067)

Event Date 01/04/2023

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: 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 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 one year, three months and eighteen days post a port placement via the right internal jugular vein, the patient allegedly developed with bacterial infection as the port site culture was positive with methicillin-resistant staphylococcus aureus.It was further reported that the patient was diagnosed with staphylococcus aureus bacteremia with severe sepsis and was managed with antibiotic therapy, and the infected port was removed.Reportedly, approximately two weeks post the port removal, the patient was expired due to respiratory failure.

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.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 through litigation process that one year, three months and eighteen days post a port placement via the right internal jugular vein, the patient allegedly developed with bacterial infection as the port site culture was positive with methicillin-resistant staphylococcus aureus.It was further reported that the patient was diagnosed with staphylococcus aureus bacteremia with severe sepsis and was managed with antibiotic therapy, and the infected port was removed.Reportedly, approximately two weeks post the port removal, the patient was expired due to respiratory failure.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The medical record provided states that there was infection and patient death with preliminary cause of respiratory failure.The infection was stated in the medical record to involve the port site.The allegation of infection is confirmed.No causal relationship between the infection and the patient death has been established.A review of the instruction for use for this product found that the following is a known complication: "infection, including but not limited to pocket, catheter tunnel, and/or blood stream.Based on the available information, the definitive root cause of the infection is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) found that the product labeling was adequate.Possible complications : ¿ infection, including but not limited to pocket, catheter tunnel, and/or blood stream ¿ intended for single use.Do not reuse.Reuse and/or repackaging may create risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure and/or lead to injury, illness or death of the patient.¿ examine package carefully before opening to confirm its integrity and that the expiration date has not passed.The device is supplied in a double sterile package and is non-pyrogenic.Do not use if package is damaged, opened or the expiration date has passed.Sterilized by ethylene oxide.Do not resterilize.Implantation preparation : create sterile field and open tray note: the catheter and port may be soaked in sterile normal saline prior to placement.H10: d4 (expiry date: 08/2022), g3, h6 (method) h11: h6 (result, conclusion) 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 CLEARVUE ISP 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: 18683332
• MDR Text Key: 335069340
• Report Number: 3006260740-2024-00446
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027369
• UDI-Public: (01)00801741027369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122899
• 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,Followup
• Report Date: 04/10/2024

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: 5608062
• Device Lot Number: REFU1584
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/01/2024; 04/10/2024
• Supplement Dates FDA Received: 03/29/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: White