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

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
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 reaz1037 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reaz1037) have been reported from the same facility.
Event or Problem Description
Per sales rep, the facility reported while placing a picc line, the (red) handle broke off when attempting to break the peel away introducer.The vascular access nurse was unable to grasp the remaining grey portion of the introducer and used sterile hemostats to peel away the remaining catheter at the insertion site.This report address patient two.

• Brand Name: POWERPICC 5F TL HF 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: 6663385
• Report Number: 3006260740-2017-00895
• Device Sequence Number: 13838071
• Product Code: LJS
• UDI-Device Identifier: 00801741129568
• UDI-Public: (01)00801741129568(17)180331(10)REAZ1037
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

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: N/A
• Device Catalogue Number: CK000653
• Device Lot Number: REAZ1037
• 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: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1