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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18FR X 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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CARDINAL HEALTH BALLOON SLG 18FR X 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 718250
Device Problem Unintended Deflation (4061)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2022
Event Type  malfunction  
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
Event Description
The customer reported that in recent days they bought a gastrostomy button and after applying it to the patient, it came out two days later.It is evident that there is water leaking out of the balloon at the tip, apparently due to the assembly of the tube and the balloon.
 
Event Description
The customer reported that in recent days they bought a gastrostomy button and after applying it to the patient, it came out two days later.It is evident that there is water leaking out of the balloon at the tip, apparently due to the assembly of the tube and the balloon.Per additional information provided by the customer on march 03, 2023, the device was replaced to resolve the issue.
 
Manufacturer Narrative
Sections b5 (describe event or problem) and h6 (health effect - impact code) have been updated to reflect additional information provided by the customer.
 
Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on may 19, 2021.There were no photos or physical sample received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.However, a supplier corrective action request has been sent to the supplier to further investigate the reported condition.If a sample is received at a later date, the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.
 
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Brand Name
BALLOON SLG 18FR X 2.5CM
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
CARDINAL HEALTH
777 west street
mansfield MA 02048
Manufacturer (Section G)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX   22500
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key16471138
MDR Text Key310551010
Report Number9612030-2023-03598
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number718250
Device Catalogue Number718250
Device Lot Number2113126564
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
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