MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD GW PAMP SAFE 20F; FEEDING DEVICE

Model Number	003030
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.A sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged missing component (lidocaine) issue due to the fact that no sample was returned for evaluation.A definitive root cause could not be determined.A review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date: 09/2020).
Event or Problem Description
It was reported that the lidocaine component was allegedly missing from the kit.There was no patient contact.

• Brand Name: BARD GW PAMP SAFE 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9845057
• Report Number: 3006260740-2020-00867
• Device Sequence Number: 2856098
• Product Code: KNT
• UDI-Device Identifier: 00801741081170
• UDI-Public: (01)00801741081170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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: Health Professional
• Device Model Number: 003030
• Device Catalogue Number: 003030
• Device Lot Number: HUDV1675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR