MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3194335
Health Effect - Clinical Code	No Information (3190)
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reby0888 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the wires had a small kink in them just where the tip becomes floppy.No other information was provided.
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 kinked guidewire was inconclusive due to non-original product sample returned.The product implicated with the reported lot number is a 135 cm guidewire.One 180 cm guidewire was returned within a bard guidewire hoop.The guidewire extended approximately 45 cm outside of the hoop.Residual use material was present on the sample.The tip of the guidewire was observed to have a bend and a kink; however, since the returned sample does not resemble a bard/bd device and is not the guidewire included in the kit with the reported product number, the state of the original guidewire remains unknown.Therefore, the complaint is inconclusive due to non-original product sample.A lot history review (lhr) of reby0888 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the wires had a small kink in them just where the tip becomes floppy.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN)
• 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: 7268664
• Report Number: 3006260740-2018-00201
• Device Sequence Number: 19164640
• Product Code: LJS
• UDI-Device Identifier: 00801741027772
• UDI-Public: (01)00801741027772
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: 3194335
• Device Catalogue Number: 3194335
• Device Lot Number: REBY0888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1