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	5829502
Medical Device Problem Codes	Difficult to Flush (1251); Suction Problem (2170); Failure to Infuse (2340); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will 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.(expiry date: 08/2022).
Event or Problem Description
It was reported that some time post port placement, the port allegedly had a difficulty in flush, difficulty to infuse, unable to aspirate and septum dislodged.There was no reported patient injury.
Additional 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 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: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported difficulty to flush, material protrusion, infusion and aspiration issue as no objective evidence was provided for review.Based upon the available information, the definitive root cause for this event is unknown.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: 08/2022), 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.H3 other text : device not returned.
Event or Problem Description
It was reported that some time post port placement, the port allegedly had difficulty in flushing, infusing and unable to aspirate.It was further reported that the septum has been dislodged.There was no reported patient injury.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• 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
• MDR Report Key: 12073584
• Report Number: 3006260740-2021-02464
• Device Sequence Number: 14588053
• Product Code: LJT
• UDI-Device Identifier: 00801741027406
• UDI-Public: (01)00801741027406
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: 5829502
• Device Catalogue Number: 5829502
• Device Lot Number: REEX1383
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1550-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other