MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NBR GASTROSTOMY TUBE 20F (EXPORT ONLY); TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000702
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2016
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 was discarded at due to expire of stock period after visual inspection.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Discarded at (b)(4) due to the expire of stock period after visual inspection.
Event or Problem Description
It was reported that the cap of feeding port could not be closed tightly, and the leakage was observed from there.The leakage had continued since the placement of the device.

• Brand Name: PONSKY NBR GASTROSTOMY TUBE 20F (EXPORT 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: 6778586
• Report Number: 3006260740-2017-01258
• Device Sequence Number: 18866590
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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: 000702
• Device Catalogue Number: 000702
• 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: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1