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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

It was reported that approximately two years of post port placement procedure, the reservoir of the lateral port allegedly found to be leaked.It was further reported that the port was removed and lateral septum partially popped out of port.There was no reported patient injury.

Manufacturer Narrative

A voluntary recall has been initiated for the powerport tm duo m.R.I.Tm implantable port which was product catalog/lot number specific.Reportedly, the power port duo m.R.I.Implantable ports are having difficulty in flushing, infusion, and/or aspiration, and septum dislodgements during use.As a result of the field action, this event is being reported as a malfunction reportable event.As the lot number for the device was provided, a review of the device history record was performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 12/2021).

Manufacturer Narrative

H10: a voluntary recall has been initiated for the powerport tm duo m.R.I.Tm implantable port which was product catalog/lot number specific.Reportedly, the power port duo m.R.I.Implantable ports are having difficulty in flushing, infusion, and/or aspiration, and septum dislodgements during use.As a result of the field action, this event is being reported as a malfunction reportable event.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 physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported leakage and septum dislodgement issues as no objective evidence was provided for review.The definitive root cause could not be determined based upon 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 (expiry date: 12/2021).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.H3 other text : device not returned.

Event Description

It was reported that approximately two years of post port placement procedure, the reservoir of the lateral port allegedly found to be leaked.It was further reported that the port was removed and lateral septum partially popped out of port.There was no reported patient injury.

Manufacturer Narrative

A voluntary recall has been initiated for the powerport tm duo m.R.I.Tm implantable port which was product catalog/lot number specific.Reportedly, the powerport duo m.R.I.Implantable ports are having difficulty in flushing, infusion, and/or aspiration, and septum dislodgements during use.As a result of the field action, this event is being reported as a malfunction reportable event.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: one powerport mri duo 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 and fluid leak issue as one of the two port septa(left) was partially dislodged and upon infusing the port, leak was noted from the partially dislodged septum.Further during functional evaluation mandrel test was performed were the left port stem failed the mandrel test as the black mark was not fully inserted into the 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 (expiry date: 12/2021).H11: section a through f ¿ the information provide 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 approximately two years of post port placement procedure, the reservoir of the lateral port allegedly found to be leaked.It was further reported that the port was removed and lateral septum partially popped out of port.There was no reported patient injury.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13768771
• MDR Text Key: 287181508
• Report Number: 3006260740-2022-00797
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1829500
• Device Catalogue Number: 1829500
• Device Lot Number: REEU3063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/22/2022; 05/05/2022
• Supplement Dates FDA Received: 03/25/2022; 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1550-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown