MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DL 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	CK000209A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 16xb6884 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility via the sales rep that the dl picc was placed on (b)(6) 2017.On (b)(6) 2017 the facility realized one of the lumens broke off where it meets the purple hub while it was in the patient.They had to place a new picc.On 06/06/17 - additional information received via paperwork from facility/sales rep.The red lumen was noted to be detached from the picc line and lying in the patient¿s bed, no blood present in the patient¿s bed.The healthcare professional questioned if the line had already clotted and walled off.It was noted that the patient had pulled the extension leg of the picc.The line was intact approximately 3 hours prior and flushed successfully.The picc line was immediately removed, it was noted that 48 cm was out of the patient and 48cm remained in the patient.No patient injury was reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for review.A lot history review (lhr) of 16xb6884 showed no other similar product complaint(s) from this lot number.Documentation regarding the event was the only item returned for investigation.
Event or Problem Description
It was reported by the facility via the sales rep that the dl picc was placed on (b)(6) 2017.On (b)(6) 2017 the facility realized one of the lumens broke off where it meets the purple hub while it was in the patient.They had to place a new picc.06/06/2017 - additional information received via paperwork from facility/sales rep.The red lumen was noted to be detached from the picc line and lying in the patient¿s bed, no blood present in the patient¿s bed.The healthcare professional questioned if the line had already clotted and walled off.It was noted that the patient had pulled the extension leg of the picc.The line was intact approximately 3 hours prior and flushed successfully.The picc line was immediately removed, it was noted that 48 cm was out of the patient and 48cm remained in the patient.No patient injury was reported.

• Brand Name: POWERPICC 5F DL 3CG
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6648358
• Report Number: 3006260740-2017-00843
• Device Sequence Number: 13740738
• Product Code: LJS
• UDI-Device Identifier: 00801741124150
• UDI-Public: (01)00801741124150(10)16XB6884
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: CK000209A
• Device Catalogue Number: CK000209A
• Device Lot Number: 16XB6884
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/02/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR