MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM); PERCUTANEOUS, IMPLANTED, LONG TERM IV CATHETER

Model Number	3174355
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 was discarded after the event occurred.A lot history review (lhr) of rebu0094 showed no other similar product complaint(s) from this lot number.Sample was discarded by facility.
Event or Problem Description
It was reported by the patient that they had a powerpicc placed in october 2017.The facility stated that the picc was cracked where the catheter enters the hub.Catheter was removed and replaced.No patient injury reported.

• Brand Name: POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM)
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM IV CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7132369
• Report Number: 3006260740-2017-02278
• Device Sequence Number: 912937
• Product Code: LJS
• UDI-Device Identifier: 00801741027635
• UDI-Public: (01)00801741027635
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: 3174355
• Device Catalogue Number: 3174355
• Device Lot Number: REBU0094
• 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: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1