MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GW PEG SD 20F KIT; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	010061
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, as the device remains in the patient.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that nurse states her patient has a peg and the cap allegedly keeps popping open and stomach fluids are leaking.The duel port adapter was replaced, but the issue allegedly persists.Patient is using tape to keep the cap in place.Tape is removed when they need to access to flush.Currently the device is only being opened to flush and then is being taped down to stay in place.The patient is not using the g-tube as a feeding device.Patient is currently stable and able to eat orally, but anticipates the patients condition will progress requiring the g-tube to be used for nutrition.

• Brand Name: GW PEG SD 20F KIT
• Common Device Name: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6769403
• Report Number: 3006260740-2017-01230
• Device Sequence Number: 149490
• Product Code: KNT
• UDI-Device Identifier: 00801741081217
• UDI-Public: (01)00801741081217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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 Model Number: 010061
• Device Catalogue Number: 010061
• Was Device Available for Evaluation?: No
• Event Location: Nursing Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1