MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INTL DELUXE PULL PEG 20F; PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING DEVICES

Model Number	000627
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, the investigation is inconclusive for the break and fluid leak, as no objective evidence has been provided to confirm any alleged deficiency with the feeding device.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 events indicated that model 000627 feeding device allegedly experienced a break and fluid leak.This report was received from one source.The device was used in the patient.Age, weight, gender and status of the patient were not provided.

• Brand Name: INTL DELUXE PULL PEG 20F
• 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: 8528287
• Report Number: 3006260740-2019-00951
• Device Sequence Number: 13921029
• Product Code: KNT
• UDI-Device Identifier: 00801741081071
• UDI-Public: (01)00801741081071
• 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): 04/18/2019

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: 000627
• Device Catalogue Number: 000627
• Device Lot Number: HUBX2521
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1