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

Model Number	000702
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.The lot met all release criteria.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 assembled ponsky nbr tube with 2 gauze sheets was returned for evaluation.Visual evaluation was performed.The investigation is inconclusive for a missing obturator, as the device as returned, outside of packaging, did not allow for confirmation that the ponsky kit was not packaged with the obturator or otherwise missing.The definitive root cause could not be determined based upon available information as the complaint could not be confirmed.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 702 feeding device experienced a missing component.This report was received from one source.There was no patient involvement.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: 8533222
• Report Number: 3006260740-2019-01089
• Device Sequence Number: 1303646
• 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: RECR2196
• 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