MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SHERLOCK 3CG BARD MYPICC KIT (5F) (DUAL-LUMEN) (TPS); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
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 device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of 17eb8650 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the patient that he has a picc that won't flush.The patient's fiancé stated that the picc was placed on (b)(6) 2017.The nurse showed the fiancé how to flush the picc and in the hospital the purple lumen would not flush, they stated that the iv team fixed it before he was discharged.They also stated that while in the hospital the red lumen wouldn't flush.When he was discharged and got home, the purple lumen would not flush.They stated that the home health nurse showed the fiancé how to use either side of the picc.He stated that the home health nurse was coming back tomorrow.The patient was transferred to (b)(6) for additional questions he had.

• Brand Name: POWERPICC SHERLOCK 3CG BARD MYPICC KIT (5F) (DUAL-LUMEN) (TPS)
• 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: 6816900
• Report Number: 3006260740-2017-01416
• Device Sequence Number: 13853194
• Product Code: LJS
• UDI-Device Identifier: 00801741043505
• UDI-Public: (01)00801741043505
• Combination Product (Y/N): N
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

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: N/A
• Device Catalogue Number: CK000229A
• Device Lot Number: 17EB8650
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1