MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD DELUXE GUIDEWIRE PEG SYSTEM 20F WITH SOFT SILICONE RETENTION DOME; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000793
Health Effect - Clinical Code	No Patient Involvement (2645)
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 for evaluation.A lot history review (lhr) of hubx2629 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the device was not used on the patient.As the device was removed from the packaging it was noted to be bent.Another guidewire was readily available to complete the procedure.No delay.No patient injury reported.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Upon receiving additional information about the event, it was determined that a reportable event had not occurred.
Event or Problem Description
It was reported that the device was not used on the patient.As the device was removed from the packaging it was noted to be bent.Another guidewire was readily available to complete the procedure.No delay.No patient injury reported.

• Brand Name: BARD DELUXE GUIDEWIRE PEG SYSTEM 20F WITH SOFT SILICONE RETENTION DOME
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7370259
• Report Number: 3006260740-2018-00522
• Device Sequence Number: 16650001
• Product Code: KNT
• UDI-Device Identifier: 00801741000478
• UDI-Public: (01)00801741000478
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: 000793
• Device Catalogue Number: 000793
• Device Lot Number: HUBX2629
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1