MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F BASIC TRAY; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of roughness along the catheter is confirmed, but the cause cannot be determined.The sample returned was a segment of powerpicc catheter tubing, without bifurcation or extension legs, etc.Visual and tactual evaluation found that the sample manifested extra material at various points on the catheter tubing.Microscopic evaluation found the material in question to be whitish/clear and apparently stuck to the catheter.Various particulate were noted to be stuck in the material.The source of this adhesive material is uncertain.However, potential causes may include deposition of adhesive prior to insertion or upon removal, particularly if the catheter came in contact with an adhesive dressing.A lot history review (lhr) of reav2378 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reav2378) have been reported from the same (b)(4) facility.
Event or Problem Description
It was reported that nurse noticed roughness of the outer portion of the catheter along the centimeter marks when running her fingers along the edge compared to other catheters.It was stated the nurse felt an increase in "bumpiness" rather than smoothness.The procedure was completed and the catheter left in situ.The catheter was later removed.This reported addresses catheter three.

• Brand Name: POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F BASIC TRAY
• 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: 6990369
• Report Number: 3006260740-2017-01927
• Device Sequence Number: 1183903
• Product Code: LJS
• UDI-Device Identifier: 00801741028618
• UDI-Public: (01)00801741028618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 9194118
• Device Lot Number: REAV2378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1