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

Model Number	CK000525A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reex0272 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a guide wire frayed.Additional information received 3/17/2021: it was reported the tip of the guide wire was frayed upon removal during a picc line insertion procedure.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a frayed guidewire was confirmed, but the exact cause could not be determined from the two images that were provided for investigation.The images showed a guidewire with the coil wire stretched over the distal end of the core wire.The distal tip of both the core wire and the coil wire was observed in the photos, but the weld tip did not appear to be present.The proximal end of the guidewire was positioned within the guidewire hoop.The blue tip straightener had been removed from the hoop.This type of damage can occur if the guidewire is retracted through the introducer needle during use; however, the exact cause of the damage could not be determined from the photograph.A review of the manufacturing records showed no evidence that the reported event was caused by the manufacturing process.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that a guide wire frayed.Additional information received 3/17/2021: it was reported the tip of the guide wire was frayed upon removal during a picc line insertion procedure.

• Brand Name: POWERPICC SOLO FT 3CG 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: 11576702
• Report Number: 3006260740-2021-01005
• Device Sequence Number: 11628012
• Product Code: LJS
• UDI-Device Identifier: 00801741124075
• UDI-Public: (01)00801741124075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: CK000525A
• Device Catalogue Number: CK000525A
• Device Lot Number: REEX0272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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