MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG SAFETY 20FR, GW, MEDICON; PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING DEVICES

Model Number	006036
Medical Device Problem Codes	Material Frayed (1262); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 006036 feeding device experienced a defective component.This report was received from one source.Of this event, the device was used on the patient with no reported injury.The age, sex, and weight of the patient were not provided.The 006036 feeding device was returned to the manufacturer.The device is pending investigation.
Additional Manufacturer Narrative
The lot number for the malfunction was not provided.The device has been returned for evaluation; the evaluation identified material frayed.The investigation is confirmed for material frayed.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 006036 feeding device allegedly experienced a defective component.This report was received from one source.Of this event, the device was used on the patient with no reported injury.The age, sex, and weight of the patient were not provided.

• Brand Name: PEG SAFETY 20FR, GW, MEDICON
• Common Device Name: PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING DEVICES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532941
• Report Number: 3006260740-2019-01077
• Device Sequence Number: 16632938
• Product Code: KNT
• UDI-Device Identifier: 00801741081194
• UDI-Public: (01)00801741081194
• 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,Followup
• Report Date (Section B): 07/24/2019

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: 006036
• Device Catalogue Number: 006036
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1