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

Model Number	5829502
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional 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.The lot number for the device was provided, a review of the device history record is currently being performed.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.(expiry date: 05/2022).
Event or Problem Description
It was reported that post port device implant, the device was allegedly difficult to flush but had a good blood return.There was no reported patient injury.
Event or Problem Description
It was reported that post port device implant, the device was allegedly difficult to flush but had a good blood return.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 fourth complaint reported for this product/lot number combination.A device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Therefore, the reported difficulty of flushing 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.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT
• 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: 11716060
• Report Number: 3006260740-2021-01503
• Device Sequence Number: 3833130
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 03/29/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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
• Patient Age: 73 YR
• Patient Weight: 32