MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG SAFETY 20FR, GW, MEDICON; FEEDING DEVICE

Model Number	006036
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the complaint history review (chr), this is the first complaint reported for this lot number.One peg safety infusion 20f kit, along with alleged foreign material in separate sealed package was received for evaluation.Visual evaluation was performed, and the foreign material appeared to be a segment of plastic tubing approximately 3.5 cm in length.The investigation is inconclusive for foreign material as the device was not returned in its original sealed tray and it is unknown where the alleged foreign material could have come into the packaging of the kit.The definitive root cause could not be determined based upon available information.It is unknown if clinical/manufacturing/shipping procedures issues contributed to the reported event.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 006036 feeding device allegedly had foreign material on the shaft of the device.The foreign material was removed and placement of the device was completed.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• Brand Name: PEG SAFETY 20FR, GW, MEDICON
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8821970
• Report Number: 3006260740-2019-02158
• Device Sequence Number: 2484912
• 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
• 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: HUCS2397
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1