MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1809601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cellulitis (1768); Erythema (1840); Unspecified Infection (1930)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the patient allegedly developed an infection.The current status of the patient is unknown.
Event or Problem Description
It was reported through litigation process that approximately one month and twenty days post a port placement for chemotherapy treatment, the patient allegedly developed with erythema.It was further reported that patient was diagnosed with bacterial infection and cellulitis.Reportedly, the port was removed and new port has been implanted.However, the current status of the patient was unknown.
Additional 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 (expiry date: 07/2023), g2, g3.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.
Additional 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: a device was not returned for evaluation.Medical records were provided and reviewed.Approximately one month and twenty days post port placement, patient presented to office yesterday with drainage, erythema and induration over his port concerning for infection.Blood culture was taken which showed staphylococcus aureus.Around a day later, patient underwent port removal procedure.One removal, the pocket was then irrigated with saline and no further purulent drainage, or necrotic tissue noted.An incision was made over the area of fluctuance in the right neck near where had previously made a right skin neck for placement of the wire and dilator during the original surgery.This area was likely just inflamed with cellulitis.After the port was irrigated again, it was packed with wet to dry keflix and covered with dry gauze.Around five months and twenty-three days later, patient underwent new port placement procedure.After new port placement, fluoroscopy confirmed appropriate placement at the cavo atrial junction.Fluoroscopy confirmed that there was no kinking in the tubing.The port was secured in the pocket.Therefore, the investigation is confirmed for the reported adverse events based on the medical records.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: d4 (expiration date: 07/2023), 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.
Event or Problem Description
It was reported through litigation process that approximately one month and twenty days post a port placement for chemotherapy treatment, the patient allegedly developed with erythema.It was further reported that patient was diagnosed with bacterial infection and cellulitis.Reportedly, the port was removed, and new port has been implanted.However, the current status of the patient was unknown.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F
• Common Device Name: 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: 19761334
• Report Number: 3006260740-2024-03828
• Device Sequence Number: 21063026
• Product Code: LJT
• UDI-Device Identifier: 00801741027147
• UDI-Public: (01)00801741027147(17)230731(10)REGN2327
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1809601
• Device Lot Number: REGN2327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 09/18/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/22/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male