MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER 3CG STYLET 5F DL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000758
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "on picc line placement, vas specialist was unable to get the yellow waveform intrathoracic visable on the picc monitor.Usual suspects were checked.Specialist took the stylet out of the picc and recalibrated and then reinserted the stylet into the picc line.At this time during the procedure, the vas specialist noticed approximately 4 cm of the tip of the stylet was hanging loose and when this area was touched it broke completely off of the end of the stylet." additional information received 04/02/2021: per specialist: started out standard procedure but noticed he did not get a normal waive form.Checked connections, flushed catheter again and with no luck he then pulled the wire back completely back to recalibrate.At that point he could see the tip of the wire, noticed something did not look right so when he touched the wire to look closer, he noticed approx.4 cm¿s hanging off of stylet.Wire was broke.Was there patient harm reported?: no because wire broke outside of pt.They did x-ray just to make certain and showed no signs of the wire in the pt.

• Brand Name: POWERPICC FT CATHETER 3CG STYLET 5F DL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11680374
• Report Number: 3006260740-2021-01382
• Device Sequence Number: 14221331
• Product Code: LJS
• UDI-Device Identifier: 00801741141140
• UDI-Public: (01)00801741141140
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: CK000758
• Device Catalogue Number: CK000758
• Device Lot Number: REEV1525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other