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

Catalog Number 1808560

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Fungal Infection (2419)

Event Date 05/06/2023

Event Type  Injury  

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.Medical records were not provided.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.Based on 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: d4 (expiration date: 05/2025).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 sometime post a port placement, the patient allegedly developed infection.However, the current status of the patient is unknown.

Event Description

It was reported through litigation process that eight months and twenty-seven days post a port placement, the patient allegedly experienced bacterial and fungal infection.It was further reported that the patient was started on antibiotics and antifungal medications and the port was removed.However, the current status of the patient is unknown.

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.Medical records were provided and reviewed.Approximately eight months and twenty-six days post port placement, patient presented to the emergency department for increased confusion and temperature 101.7 f.He had a port in place for iv infusion for every two weeks.No signs of site infection, however presumed clabsi.Computed tomographic chest was performed which showed multiple tiny pulmonary nodules of the upper lobes measuring up to 5 mm.Atelectasis and scarring of the lower lobes and lingula.Around one day later, blood culture noted positive for mycobacterium fortuitum and started on iv levaquin, imipenem and amikacin on seventh day.Around three days later, patient underwent port removal procedure.The catheter tip cultures positive for >15 colonies of candida dublinensis and oxacillin sensitive s.Hominis.Around sixteen days later, patient was started on micafungin and transitioned to fluconazole which will be concluded.Around twenty-five days later, patient was returned to rehabilitation center.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.Based on 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: d4 (expiration date: 05/2025), g2, g3, h6 (method).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 M.R.I. IMPLANTABLE PORT, GROSHONG 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: 18569380
• MDR Text Key: 333547515
• Report Number: 3006260740-2023-06156
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• 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: 03/04/2024

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: 1808560
• Device Lot Number: REGR4501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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: 45 YR
• Patient Sex: Male