MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F BA; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redx2449 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2449) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that guidewire broke off in a patient while inserting a picc.Insertion site: venous left; technique: picc; cm+ intrnal length: 42cm; left cephalic vein unable to thread past 30 cm.Guidewire broke mid procedure.All pieces recovered.
Event or Problem Description
It was reported that guidewire broke off in a patient while inserting a picc.Insertion site: venous left technique: picc cm+ intrnal length: 42cm left cephalic vein unable to thread past 30 cm.Guidewire broke mid procedure.All pieces recovered.
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, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet was confirmed but the exact cause was unknown.The product returned for evaluation was a tls stylet.The sample was returned with a complete break within the magnetic tip which resulted in a detached segment measuring 2.7cm in length.Blood-like usage residue was seen on the t-lock assembly and warning tag.White crystalline residue was also seen on the detached segment.The polyimide tubing was microscopically inspected for evidence of damage, defect, or deformity, which may have existed prior to the event, and none was found.The break was observed to have occurred at the edge of a fractured magnet and the shrink tube was slightly pulled into the break which was evidence that a sharp kink had occurred at that site.One other minor kink was observed in the detached segment.The damage at the break site precluded accurate measurement at the break.Further measurements of the polyimide wall thickness at seven points between the t-lock assembly and magnet tip found all to be within specification.The damage seen on the sample was indicative of the stylet having been kinked at a large angle, and potentially pulled while being kinked; however, the exact conditions contributing towards the stylet break were unknown.A lot history review (lhr) of redx2449 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2449) have been reported from the same facility in canada.

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F BA
• 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: 9765480
• Report Number: 3006260740-2020-00647
• Device Sequence Number: 2496707
• Product Code: LJS
• UDI-Device Identifier: 00801741035913
• UDI-Public: (01)00801741035913
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 9395118Q
• Device Lot Number: REDX2449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1