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

Catalog Number 1808060

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

Patient Problems Sepsis (2067); Osteomyelitis (4533)

Event Date 01/09/2022

Event Type  Injury  

Event Description

It was reported through litigation process that seven months seven days post a port placement, the patient allegedly developed with bacteremia, sepsis and osteomyelitis.It was further reported that the infected port was removed.However, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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 device was not returned for evaluation.Medical records were provided and reviewed.Approximately seven months and six days post port placement, patient presented to the emergency room with epistaxis that has been persistent over the last day.He also developed increased shortness of breath and started having fevers as high after admission.Around one day later, patient had an infectious disease consultation for bacteremia in immunocompromised host.His blood cultures are now growing mssa.Ct chest shows evidence of haziness in the right sternoclavicular angle that seems to be nonspecific but possibility of septic joint or osteomyelitis is not completely excluded.He was diagnosed with sepsis, mssa bacteremia, port infection, possible sternoclavicular osteomyelitis/septic arthritis, chronic lymphocytic leukemia and epistaxis.He was on cefepime and strongly recommended discontinuation of port followed by repeat blood culture.High grade bacteremia with staphylococcus aureus.Around one day later patient underwent removal of right chest port and catheter, irrigation and debridement of right chest wound soft tissue and packing of open right chest wound.The tip of catheter sent to microbiology for culture/stain of afb, fungal, aerobic and anaerobic bacteria.Around eleven days later, patient status improved and discharged to home.Around two months and twenty-one days later, patient presented for ongoing infections in the port area.He has been taking antibiotics off and on in outpatient.Mri of the chest showed concern for osteomyelitis of the surrounding bone.Cultures were drawn and he was started on broad spectrum antibiotic.Around two months and nine days later, patient underwent debridement of sternoclavicular joint infection with partial resection of manubrium and partial resection of the clavicle.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.Furthermore, the 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: 06/2022).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 ISP 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: 18928360
• MDR Text Key: 337944439
• Report Number: 3006260740-2024-01152
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027031
• UDI-Public: (01)00801741027031
• 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
• Report Date: 03/06/2024

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: 1808060
• Device Lot Number: REEZ1827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/19/2024
• 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: 66 YR
• Patient Sex: Male