MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR D/L POWERPICC BASIC TRAY W/70 CM GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 difficult guidewire insertion is confirmed but the exact cause remains unknown.One 6 fr powerpicc catheter, one stylet hoop without stylet, one guidewire hoop with a bent guidewire, one dilator without sheath, one introducer needle and additional accessory components were returned for investigation.The product label returned contained lot: reax1652.Use residue was observed on the returned components.The catheter extended up to the 37 cm depth marker.The blue tip straightener was returned separate from the hoop.Bends on the guidewire were present 3 cm and 7 cm from the proximal end of the tubing.The flexible tip was observed to have multiple bends and kinks.The outer diameter of the returned guidewire was measured and found to be within specification.A non-complainant guidewire was passed through both lumens of the catheter and residual biological material was observed to obstruct the path.The use residue was cleared and no additional obstructions were observed.The wire was passed through the introducer needle and dilator.No non-use residue obstructions were observed.Since the evidence of a difficult guidewire insertion was present, the complaint is confirmed; however, the exact cause remains unknown.A lot history review (lhr) of reax1652 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion, it is difficult to advance picc through wire, (the user felt the picc tip stuck inside the patient.Then use another picc to complete).On 03/12/2019 - returned wire is kinked.

• Brand Name: 6 FR D/L POWERPICC BASIC TRAY W/70 CM GUIDEWIRE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8478952
• Report Number: 3006260740-2019-00758
• Device Sequence Number: 1871391
• Product Code: LJS
• UDI-Device Identifier: 00801741028014
• UDI-Public: (01)00801741028014
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: N/A
• Device Catalogue Number: 3276155
• Device Lot Number: REAX1652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1