MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12 FR X 0.80 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	712080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
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 states the device had to be replaced due to a rupture of the tube under the outer collar.There was no harm to the patient.
Additional Manufacturer Narrative
Evaluation summary: 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 issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Two photos and one sample were received at the manufacturing site for evaluation.The sample was visually inspected according to procedure.It was observed that there was a rupture under the outer collar.The reported condition is confirmed.A corrective and preventative action (capa) was opened to determine the root cause and corrective actions.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 12 FR X 0.80 CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 13367320
• Report Number: 9612030-2022-03146
• Device Sequence Number: 19831486
• Product Code: KNT
• UDI-Device Identifier: 10884521010475
• UDI-Public: 10884521010475
• 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
• Report Date (Section B): 04/11/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 712080
• Device Catalogue Number: 712080
• Device Lot Number: 2104813064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown