MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SL POWERPICC SOLO 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	CK000504
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
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 rebq1104 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Patient reported to medical services that he had a power picc solo single lumen placed on (b)(6) 2017, for daily iv medication.The picc worked well yesterday.When dressing was changed, the patient stated the catheter wanted to kink.When patient attempted to get medication today the picc would not flush.Advised the patient to contact the nurse about changing the picc dressing or access line for occlusion due to possible fibrin.On (b)(6) 2017 - additional information reported that the patient went to the emergency room where they changed the leur hub on the catheter.Catheter flushes and aspirates without difficulty.

• Brand Name: 4F SL POWERPICC SOLO 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: 6803429
• Report Number: 3006260740-2017-01349
• Device Sequence Number: 969682
• Product Code: LJS
• UDI-Device Identifier: 00801741100116
• UDI-Public: (01)00801741100116
• 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
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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 Expiration Date: 03/31/2018
• Device Model Number: CK000504
• Device Catalogue Number: CK000504
• Device Lot Number: REBQ1104
• 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: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1