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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
A manufacturing review was not requested as the lot number reported is unknown. Investigation summary: the physical device was not returned for evaluation. No photos were provided for review. Therefore, the investigation is inconclusive for the reported redness and soreness issues as no objective evidence was provided for review. A definitive root cause could not be determined based upon the available information. Labeling review: a review of product labeling documentation (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy. Device not returned.
Event Description
It was reported that post feeding device placement, the patient allegedly had redness and soreness and the device was removed. There was no reported patient injury.
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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 Key12860473
MDR Text Key281139646
Report Number3006260740-2021-04966
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 Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK BUTTONS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2021
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