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

Model Number 1829500

Device Problems Fluid/Blood Leak (1250); Material Protrusion/Extrusion (2979)

Patient Problems Extravasation (1842); Infiltration into Tissue (1931)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 05/2022).

Event Description

It was reported that approximately six months and fifteen days post port implant procedure, the port septum allegedly leaked.It was further reported that a pop was heard when flushing and caused infiltration of fluid under the skin.Reportedly the port was removed and replaced with another port.There was no reported patient injury.

Event Description

It was reported that approximately six months post port implant procedure, the port septum allegedly dislodged and leaked.It was further reported that a pop was heard when flushing and caused infiltration of fluid under the skin.Reportedly the port was removed and replaced with another port.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: one powerport duo mri implantable port attached to a catheter was returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported material protrusion, infiltration and fluid leak issue as one of the two port septa(right) was noted to be dislodged from the port body and upon infusing the port, leak was noted from the partially dislodged septum.Further during functional evaluation mandrel test was performed were both the port stems passed the test as the black mark on the mandrel was fully inserted within each lumen.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 05/2022).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 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: 14249616
• MDR Text Key: 290370680
• Report Number: 3006260740-2022-01556
• 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,Followup
• Report Date: 06/28/2022

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 Model Number: 1829500
• Device Catalogue Number: 1829500
• Device Lot Number: REFQ2563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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