MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 712150

Device Problem Break (1069)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

The customer reported a broken balloon.No injuries were reported.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on july 22, 2019.Per the dhr review, lot number 1919724764 is associated with item code 712150 not item code 714150 which was reported.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 and determine the root cause.However, a supplier corrective action request has been issued to further investigation and address 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.

Manufacturer Narrative

One physical sample of item code 712150 was received at the manufacturing site for investigation.The sample was visually and functionally inspected, and the reported condition was confirmed.The affected component is produced by an external supplier.A supplier corrective action request (scar) has been issued to the supplier to further investigate and address the reported condition.This complaint will be used for tracking and trending purposes.Correction made to section d4: model number/catalog number/udi.

• Brand Name: BALLOON SLG 14FR X 1.5CM
• 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 Key: 15985048
• MDR Text Key: 306244188
• Report Number: 9612030-2022-03492
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

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: 712150
• Device Catalogue Number: 712150
• Device Lot Number: 1919724764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 11/23/2022
• Supplement Dates FDA Received: 02/16/2023; 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1