MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NON-BALLOON REPLACEMENT GASTROSTOMY TUBE; FEEDING DEVICE

Model Number	000702
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based upon the severity level and lot quantity, a dhr review is not required; however, the dhr was requested to review manufacturing records.Manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.One ponsky non balloon replacement gastrostomy tube was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for hole in the feeding dome, as a small split was observed on the bumper.The split was observed on the opposite side of the obturator insertion point.The definitive root cause could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of this event indicated that model 000702 feeding device experienced material perforation.This report was received from one source.There was one patient involved with no patient consequences.Patient age, weight, and gender were not provided.

• Brand Name: PONSKY NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532541
• Report Number: 3006260740-2019-01061
• Device Sequence Number: 16624483
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: No Information
• Device Model Number: 000702
• Device Catalogue Number: 000702
• Device Lot Number: RECS2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1