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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM BUTTONS/WIZARD

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BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM BUTTONS/WIZARD Back to Search Results
Model Number 000282
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Skin Discoloration (2074); Swelling (2091)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard. The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of huaw0245 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (huaw0245) have been reported from the same facility.
 
Event Description
It was reported on (b)(6) 2017 that the dome migrated. No other information was reported, but has been requested. There was no reported patient injury. On (b)(6) 2017 - per the reporting facility, the child's parents were caring for the device on discharge home after receiving education from the facility's team. The device was intact but had migrated out of the patient's stomach. This was discovered due to the child complaining of pain, the presence of swelling and redness at the insertion site, and the device was no longer sitting flush against the skin; the shaft of the device was visible and usually on an angle there is an obvious lump at the site. There was no complication as a result of this event.
 
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Brand NameBARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM
Type of DeviceBUTTONS/WIZARD
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key7068530
MDR Text Key93898646
Report Number3006260740-2017-02145
Device Sequence Number1
Product Code KGC
UDI-Device Identifier10801741087858
UDI-Public(01)10801741087858
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K904779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number000282
Device Catalogue Number000282
Device Lot NumberHUAW0245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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