MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14FR X 1.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	714100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that due to a leaking balloon (probably a rupture), the balloon had to be replaced.Additional information was received and stated that there was no pinhole noticed in the balloon.Per customer, it was found that there was no proper sealing of the probe.Therefore, the balloon was replaced.During device replacement, there was no part of the probe (e.G, a piece of balloon) could remain in the patient¿s body was found.There was no harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The product was manufactured on (b)(6) 2021.One sample was received for the evaluation.A visual inspection and functional testing were performed.The balloon was inflated with water and a leak was detected in the lower part of the tube (pin hole at the end of the tube).Since the affected component 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.

• Brand Name: BALLOON SLG 14FR X 1.0CM
• Common Device Name: 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: 16704198
• Report Number: 9612030-2023-03669
• Device Sequence Number: 19740012
• Product Code: KNT
• UDI-Device Identifier: 10884521010628
• UDI-Public: 10884521010628
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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 Expiration Date: 06/30/2026
• Device Model Number: 714100
• Device Catalogue Number: 714100
• Device Lot Number: 2120818664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown