MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERFLOW APHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number A710962

Device Problems Reflux within Device (1522); Improper or Incorrect Procedure or Method (2017); Suction Problem (2170); Obstruction of Flow (2423)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record will not be performed.The device has been returned to the manufacturer and the evaluation is still pending.The investigation of the reported event is currently underway.

Event Description

It was reported that sometime 3 years port placement, the device allegedly malfunctioned.It was further reported that there was an initial flash back of blood.Reportedly, when the port was flushed there was a distinct bulge in the internal jugular vein.Current status of patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one powerflow apheresis iv implantable port 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 suction problem as the device was unable to be aspirated during functional evaluation.However, the investigation is inconclusive for the reported obstruction of flow, improper or incorrect procedure or method and reflux within device issues as the exact circumstances at the time of the reported event are unknown, and the reported event could not be reproduced in the lab.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.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.

Event Description

It was reported that approximately three years port placement, the device allegedly malfunctioned.It was further reported that there was an initial flash back of blood.Reportedly, when the port was flushed there was a distinct bulge in the internal jugular vein.The current status of patient is unknown.

• Brand Name: POWERFLOW APHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F
• 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
• MDR Report Key: 10745479
• MDR Text Key: 213392396
• Report Number: 3006260740-2020-20264
• Device Sequence Number: 1
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438
• Combination Product (y/n): N
• PMA/PMN Number: K163001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR