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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F; FEEDING DEVICE
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C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F; FEEDING DEVICE Back to Search Results
Model Number 000720
Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2022).
 
Event Description
It was reported that prior to a gastrostomy feeding tube placement procedure, the device was prepped by infusing water into the balloon track and the water allegedly leaked through the end hole and the device did not inflate.The procedure was completed using another device.There was no patient contact.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported leak and failure to inflate issue 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.H10: d4 (expiry date: 08/2022).H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.
 
Event Description
It was reported that prior to a gastrostomy feeding tube placement procedure, the device was prepped by infusing water into the balloon track and the water allegedly leaked through the end hole and the device did not inflate.The procedure was completed using another device.There was no patient contact.
 
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Brand Name
BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F
Type of Device
FEEDING DEVICE
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX   85621
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12958252
MDR Text Key281902980
Report Number3006260740-2021-05170
Device Sequence Number1
Product Code KNT
UDI-Device Identifier00801741037153
UDI-Public(01)00801741037153
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K063118
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number000720
Device Catalogue Number000720
Device Lot NumberNGDY2163
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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