MAUDE Adverse Event Report: CARDINAL HEALTH AQUA-SEAL CDU; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 8888571299

Device Problem Suction Problem (2170)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation comment - the customer stated that the device will not be returned for evaluation because it has been discarded.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process for the reported lot.The complaint report indicates that no sample is available in connection with this complaint report.Without a sample we are unable to perform a thorough follow up investigation to include a functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).Unfortunately, without a sample we are unable to confirm the reported condition if a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.

Event Description

Customer reports: during use on a patient, the hose that connects the equipment collapsed several times.Per additional information received on (b)(6)2022 there was a leak that did not allow the device to be used properly but the user did not identify the exact location of the leak.There was diminished suction and when the user saw that the water seal was not working properly, they tried to fix it but decided to use a new device.

• Brand Name: AQUA-SEAL CDU
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15422337
• MDR Text Key: 304805715
• Report Number: 9611018-2022-00564
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 09/14/2022

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: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 21G056FHX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1