MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1829500

Device Problems Fluid/Blood Leak (1250); Difficult to Flush (1251); Suction Problem (2170); Material Protrusion/Extrusion (2979)

Patient Problem Extravasation (1842)

Event Date 03/01/2024

Event Type  Injury  

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.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2024).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 Description

It was reported that three months and two days post a port placement, the extravasation of fluoro contrast allegedly occurred around the reservoir.It was further reported that the silicone piece had allegedly dislodged from the plastic reservoir when the old reservoir was removed.Furthermore, there was an alleged difficulty in aspirating both the lumens over the last few chemo session.Moreover, the patient allegedly complained of stinging pain during infusions of the lateral reservoir and had a tissue plasminogen activator dwell in the pre-procedure bay with improvement in the medial lumen and still unable to aspirate the lateral lumen.Reportedly, the port was removed and replaced.The current status of the patient is unknown.

Event Description

It was reported that three months and two days post a port placement, the extravasation of fluoro contrast allegedly occurred around the reservoir.It was further reported that the silicone piece had allegedly dislodged from the plastic reservoir when the old reservoir was removed.Furthermore, there was an alleged difficulty in aspirating both the lumens over the last few chemo session.Moreover, the patient allegedly complained of stinging pain during infusions of the lateral reservoir and had a tissue plasminogen activator dwell in the pre-procedure bay with improvement in the medial lumen and still unable to aspirate the lateral lumen.Reportedly, the port was removed due to port site infection and replaced.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 sample was not returned for evaluation.However, three radiographic images were provided for review.The image shows leakage at the port-catheter interface and the silicone cuff (designed to secure the catheter to the port) was found ¿dislodged".Therefore, the investigation is confirmed for the reported material protrusion, leak, difficult to flush and suction issues.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: 07/2024), g3, h6 (method).H11: b5, 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 DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• 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: 19102853
• MDR Text Key: 340107624
• Report Number: 3006260740-2024-01742
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027185
• UDI-Public: (01)00801741027185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

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: 1829500
• Device Lot Number: REHP1314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/14/2024
• 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: 21 YR
• Patient Sex: Male