MAUDE Adverse Event Report: CARDINAL HEALTH 1180505172 SELEC TROL YANK OPEN TIP; CATHETER AND TIP, SUCTION

Model Number 1180505172

Device Problem Suction Failure (4039)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that when reconditioning/draping the anesthesia site, the black button was engaged but there was no suction.No patient impact.

Manufacturer Narrative

The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot number 21k158fhx.One (1) opened sample was returned for evaluation.The black slider button was inspected and there was no evidence of excess solvent that could affect the function of the on/off slider button.The device underwent a suction test to confirm performance; the device passed the functionality test as it performed as expected.Based on the available information, the reported issue was not confirmed and a root cause could not be determined.Since this complaint will be considered unconfirmed, no corrective or preventive actions will be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 1180505172 SELEC TROL YANK OPEN TIP
• Type of Device: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14172402
• MDR Text Key: 290158809
• Report Number: 9611018-2022-00557
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1180505172
• Device Catalogue Number: 1180505172
• Device Lot Number: 21K158FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1