MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720205

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported a broken bullet.Per additional information provided on august 24, 2022, the balloon drilled.There were no fragmented pieces.The device was placed on (b)(6) 2022.There was no patient injury.Per additional information provided on august 30, 2022, when they customer says the "balloon drilled", they mean the balloon burst.The device was replaced to resolve the issue.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on october 30, 2020.The manufacturing process was reviewed, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.There were no physical samples or photos received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition or determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR
• 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 Key: 15329187
• MDR Text Key: 303402457
• Report Number: 9612030-2022-03370
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: 10884521007291
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720205
• Device Catalogue Number: 8884720205
• Device Lot Number: 2029411664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1