MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16 FR X 2.3 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 716230

Device Problem Deflation Problem (1149)

Patient Problems Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported hole in the balloon.The balloon was initially placed on (b)(6) 2022.There was no patient harm reported.

Manufacturer Narrative

The device history record was reviewed.No abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product was manufactured on 14-feb-2018.A sample have not yet been received at the manufacturing site for investigation.Because a sample was not returned, we were unable to perform a follow-up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Since the device is provided by an external supplier, a corrective action (capa) has been generated to the supplier to determine the root cause and corrective and preventive actions, if required.This complaint will be used for tracing and trending purposes.

Manufacturer Narrative

Section b5 has been updated to include additional information received along with the returned device.The device history record was reviewed.No abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product was manufactured on 14-feb-2018.The device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.The root cause and the action plan will be documented through capa.Section h6 (health effect - clinical code): originally reported as 4582 no clinical signs, symptoms or conditions and should be 4545 skin inflammation/ irritation based on the information received along with the returned device.

Event Description

The customer reported hole in the balloon.The balloon was initially placed on (b)(6) 2022.There was no patient harm reported.Per additional information received pinhole in the balloon caused dislodgement and site irritation.

• Brand Name: BALLOON SLG 16 FR X 2.3 CM
• 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: 15419139
• MDR Text Key: 305373277
• Report Number: 9612030-2022-03387
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 716230
• Device Catalogue Number: 716230
• Device Lot Number: 1833804264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1