MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F SL CATHETER RADIOLOGY BASIC TRAY (70 CM NITONOL GUIDEWIRE); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
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 reay1863 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Nurse reported that they had an introducer from a picc kit that would not break.The nurse stated that they had to clip the red plastic and on both sides to be able to break the peel away.The introducer was also cut with scissors for the nurse to be able to complete the picc procedure successfully.There was no injury to the patient.

• Brand Name: POWERPICC 5F SL CATHETER RADIOLOGY BASIC TRAY (70 CM NITONOL GUIDEWIRE)
• 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: 6312135
• Report Number: 3006260740-2017-00050
• Device Sequence Number: 16254188
• Product Code: LJS
• UDI-Device Identifier: 00801741027703
• UDI-Public: (01)00801741027703(17)171231(10)REAY1863
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/18/2017

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: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 3175355
• Device Lot Number: REAY1863
• 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: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1