MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BUTTONS / WIZARDS; FEEDING TUBE

Model Number	000287
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complete manufacturing review could not be conducted for the investigation as the lot number is unknown.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged adapter detachment as no objective evidence has been provided to confirm any alleged deficiency with the catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the 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 000287 feeding tube allegedly detached.The button was removed and replaced.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• Brand Name: BUTTONS / WIZARDS
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8813844
• Report Number: 3006260740-2019-02085
• Device Sequence Number: 2563474
• Product Code: KGC
• UDI-Device Identifier: 10801741087902
• UDI-Public: (01)10801741087902
• 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): 07/22/2019

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: 000287
• Device Catalogue Number: 000287
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1