MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1716070
Medical Device Problem Codes	Device Tipped Over (2589); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional 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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2022).
Event or Problem Description
It was reported through the litigation process that approximately two weeks post port device implant, the catheter allegedly had poor and difficult intravascular access and the port flipped sideways in the left chest pocket.It was further reported that a surgery was required to remove the port.The patient was treated using a new port implanted in the right chest.The current status of the patient is unknown.
Additional 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: the sample was not returned for evaluation, one medical record was provided for review.The investigation is confirmed for the reported port flipped and blocked connection issue.According to the medical record, approximately two weeks post port placement, the left chest port was attempted to be accessed; however, this was unsuccessful.Subsequently, a spot radiograph of the chest revealed left that the catheter appeared to be intact and the left chest port was flipped sideways in the left chest pocket.Four days later, the patient¿s pre-operative diagnosis demonstrated poor and difficult intravascular access.Eventually the left chest port was removed and replaced with new single lumen port.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.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 or Problem Description
It was reported through the litigation process that approximately two weeks post port device implant, the catheter allegedly had poor and difficult intravascular access and the port flipped sideways in the left chest pocket.It was further reported that a surgery was required to remove the port.The patient was treated using a new port implanted in the right chest.The current status of the patient is unknown.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• 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: 12106309
• Report Number: 3006260740-2021-02572
• Device Sequence Number: 3774566
• Product Code: LJT
• UDI-Device Identifier: 00801741026768
• UDI-Public: (01)00801741026768
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 1716070
• Device Catalogue Number: 1716070
• Device Lot Number: REDR0742
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR