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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BUTTONS FEEDING DEVICE

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C.R. BARD, INC. (BASD) -3006260740 BUTTONS FEEDING DEVICE Back to Search Results
Catalog Number UNK BUTTONS
Device Problems Fracture (1260); Material Separation (1562); Migration (4003)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed. The return of the sample is pending. The investigation of the reported event is currently underway. Device pending return.
Event Description
It was reported that the button tube allegedly ripped and became stuck in the feeding tube. The hcp cut the external segment of the button tube and allowed the internal segment to pass through the digestive system. The procedure was completed by using another device. Patient current status is unknown.
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Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
MDR Report Key11347186
MDR Text Key232512034
Report Number3006260740-2021-00386
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK BUTTONS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2021 Patient Sequence Number: 1