MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POLY PER-Q-CATH PICC 5F DUAL-LUMEN INTERMEDIATE TRAY WITH SAFETY INTRODUCER (60C; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3255100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2016
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged stylet was confirmed and the cause appeared to be use-related.The product returned for evaluation was one stiffening stylet.The sample was received in two segments.The proximal segment of stylet measured 73.5cm.The distal segment was comprised only of outer coil wire.The weld tip was missing and was not returned for evaluation.The inner core wire exhibited bent shape memory in the vicinity of the break.Microscopic inspection of both the break site in the inner core wire and at the distal end of the distal segment revealed regular striations and regions of increased luster.Microscopic inspection of the shared complete break in the outer coil wire revealed material necking and a granular fracture surface.The regular striations and increased luster indicated that the stylet was cut with a sharp metal instrument such as scissors.The location of the damage suggested that the stylet may have been cut when the catheter was trimmed.The product ifu states ¿do not cut the stylet.¿ the shared complete break in the coil wire was typical of damage caused by tensile stress and likely occurred during attempted stylet removal.A lot history review (lhr) of rezf0594 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - it was reported by user facility that on (b)(6) 2016 the physician was placing the device and the guidewire of the pre loaded stylet unraveled.It was said that the doctor believes that he retrieved the entire wire.No patient injury reported.

• Brand Name: POLY PER-Q-CATH PICC 5F DUAL-LUMEN INTERMEDIATE TRAY WITH SAFETY INTRODUCER (60C
• 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: 5592567
• Report Number: 3006260740-2016-00178
• Device Sequence Number: 543384
• Product Code: LJS
• UDI-Device Identifier: 00801741035043
• UDI-Public: (01)00801741035043(17)70531(10)REZF0594
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K034019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2016

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: 05/31/2017
• Device Catalogue Number: 3255100
• Device Lot Number: REZF0594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1