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

Model Number 000702

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8532541
• MDR Text Key: 142525710
• Report Number: 3006260740-2019-01061
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 000702
• Device Catalogue Number: 000702
• Device Lot Number: RECS2016
• Date Manufacturer Received: 03/31/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1