MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GW DELUXE PEG 20F - U.S. ONLY; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000793
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of hubq1719 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per ms&s, customer needs to confirm if we recently made changes to the peg guidewire kit.She described the "junction having film or tape around it." she described the "junction" as the " part where its pulled through the stomach." she stated the tape or film "almost caused the physician to switch to an open procedure".Ms&s forwarded the case to bas (b)(4).

• Brand Name: GW DELUXE PEG 20F - U.S. ONLY
• 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: 6802431
• Report Number: 3006260740-2017-01334
• Device Sequence Number: 101291
• Product Code: KNT
• UDI-Device Identifier: 00801741000478
• UDI-Public: (01)00801741000478
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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: 03/28/2019
• Device Model Number: 000793
• Device Catalogue Number: 000793
• Device Lot Number: HUBQ1719
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1