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

Catalog Number	1808002
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Extravasation (1842); Unspecified Infection (1930); Pain (1994); Skin Erosion (2075); Thrombosis/Thrombus (4440)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
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: (expiry date: 05/2023).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 or Problem Description
It was reported through litigation process that approximately one year, three months and three days post a port placement, the port catheter allegedly developed fracture and extravasation.It was further reported that catheter occluded and patient developed with infection, thrombosis, erosion and pain.Reportedly, the port was removed and new port has been implanted.However, the current status of the patient was unknown.
Event or Problem Description
It was reported through litigation process that one year, three months and three days post a port placement, the port catheter allegedly developed fracture and extravasation.It was further reported that catheter occluded and patient developed with infection, thrombosis, erosion and pain.Reportedly, the port was removed and new port has been implanted.However, the current status of the patient was unknown.
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: the device was not returned for evaluation.Medical records were provided and reviewed.Medical alleged that the patient underwent port placement procedure.A chest x-ray was performed for line placement which showed right pectoral distribution infusion port terminates in the superior vena cava.Approximately one year three months and three days later a chest x-ray was performed for chest port dysfunction.The study showed that there was extravasation from the port catheter which showed fracture of the right subclavian chest port catheter where it passes beneath the right clavicle.No contrast is seen opacifying the port catheter distal to the site of extravasation.Approximately after seventeen days of post x-ray, port was removed.Therefore, the investigation is confirmed for the reported fracture and fluid leak.However, the investigation is inconclusive for the reported obstruction of flow issue as no objective evidence found for occlusion and/or flow issue from medical records.Furthermore, clinical conditions alleged in the complaint can be confirmed.Based upon available information, the definitive root cause was unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device, method).H11: d4 (unique identifier (udi) #), 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.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 20062931
• Report Number: 3006260740-2024-04727
• Device Sequence Number: 8662371
• Product Code: LJT
• UDI-Device Identifier: 00801741026997
• UDI-Public: (01)00801741026997(17)230531(10)REFX4059
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 1808002
• Device Lot Number: REFX4059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American