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

Model Number	714100
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the patient noticed a broken balloon five days after the insertion of the probe.The probe has been replaced with a new one.Per additional information provided on july 13, 2022, the break was a clean tear, there were no fragmented pieces.
Additional Manufacturer Narrative
Section h6 "type of investigation" corrected from 4101 (testing of device from same lot/batch returned from user) to 10 (testing of actual/suspected device).
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 dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on august 04, 2021.One decontaminated nutriport with lot 2120818664 was received at the manufacturing site for investigation.A visual inspection and functional test were performed, and the reported condition was confirmed.The balloon was inflated with water and left for a few minutes and a leak was observed.The affected component is product by a supplier.A supplier corrective action request (scar) has been issued to the supplier for further investigation.This complaint will be used for tracking 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: 15052475
• Report Number: 9612030-2022-03326
• Device Sequence Number: 5439218
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 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): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 07/08/2022; 07/08/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/23/2022
• 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