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 Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary : the device was not returned for evaluation.Therefore, the reported material protrusion issues cannot be confirmed.Based upon the available information a definitive root cause could not be determined.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.(expiry date: 05/2022).
Event or Problem Description
It was reported that post port placement, the device allegedly had a material protrusion.There was no reported patient injury.
Event or Problem Description
It was reported that post port placement, the device allegedly had a material protrusion.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 complaint history review was performed.This is the thirty second complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary : the device was not returned for evaluation.Therefore, the reported material protrusion issues cannot be confirmed.Based upon the available information a definitive root cause could not be determined.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: 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.H3 other text : device not returned.

• 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: 11796078
• Report Number: 3006260740-2021-01767
• Device Sequence Number: 14180716
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: REEV2356
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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: UNKNOWN
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other