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 1608062

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

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 09/08/2022

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

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 photos were provided for review.Medical records were not provided.Therefore, the investigation is inconclusive for the reported clinical condition 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.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 seven months and twenty-seven days post a port placement via the left internal jugular vein, the patient allegedly developed with an infection.It was further reported that the patient allegedly experienced extensive cellulitis of the skin.Reportedly, the port and catheter were freed from the pocket and removed in their entirety.The current status of the patient is unknown.

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: 01/2023).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 seven months and twenty-seven days post a port placement via the left internal jugular vein, the patient allegedly developed with an infection.It was further reported that the patient allegedly experienced extensive cellulitis of the skin.Reportedly, the port and catheter were freed from the pocket and removed in their entirety.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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 physical device was not returned for evaluation.Medical records were provided.The medical record states that the patient underwent insertion of single lumen left internal jugular vein mediport under fluoroscopy.A wire was advanced into the right atrium into the inferior vena cava and a pocket was created using blunt dissection.The port was assembled, flushed and a port reservoir was seated in the pocket by tunneling.The tip of the catheter was placed in the right atrium.The port was tested and functioned well.Six months later, patient underwent explantation for port site ulceration.There was extensive erythema of the skin and subcutaneous tissues of the pocket.Due to extensive cellulitis and concern for pocket infection, the wound was packed with iodoform gauze.Therefore, it can be confirmed that the patient experienced cellulitis and infection.However, the relationship to the port is unknown.Furthermore, the clinical condition 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.H10: d4 (expiration date: 01/2023), g3, h6 (method).H11: h6 (result, conclusion).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 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: 18998528
• MDR Text Key: 338875427
• Report Number: 3006260740-2024-01338
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: (01)00801741026430
• 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,Followup
• Report Date: 05/17/2024

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: 1608062
• Device Lot Number: REFV1318
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/10/2024; 05/28/2024
• Supplement Dates FDA Received: 05/01/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2021
• 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
• Patient Age: 47 YR
• Patient Sex: Female