MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 18F X 1.2 CM BUTTON KIT; FEEDING DEVICE

Model Number 000292

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 000292 feeding device allegedly experienced fluid leak.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

Manufacturer Narrative

For the reported event, lot number was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 000292 feeding device allegedly experienced fluid leak.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: 18F X 1.2 CM BUTTON KIT
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; lot #1, road #3, km 79.7; salt lake city UT 84116
• MDR Report Key: 9946789
• MDR Text Key: 195788060
• Report Number: 3006260740-2020-01232
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087919
• UDI-Public: (01)10801741087919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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
• Device Operator: No Information
• Device Model Number: 000292
• Device Catalogue Number: 000292
• Device Lot Number: HUBY0564
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/14/2020
• Patient Sequence Number: 1