MAUDE Adverse Event Report: CARDINAL HEALTH PROBE 5MM X 33CM, DISP FIXED; CATHETER, IRRIGATION

Model Number ASU1201

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record for the above lot has been reviewed for conformance to the cardinal health specifications.The product is tested 100% for leaks.Specifically, the ¿aspiration button¿ is depressed, opened and closed several times during the test for leaks, and visual integrity appears to be in conformance.There has been no other complaint from this lot.Testing had been performed prior to final packaging and sterilization and met all requirements.The product has not been returned for review and therefore the exact cause cannot be determined without sample for evaluation.Cardinal health has issued a voluntary recall on 6/11/2018 for this product.

Event Description

The issue was met with 3 medical devices of this type: a lack of aspiration and washing.

• Brand Name: PROBE 5MM X 33CM, DISP FIXED
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 7773297
• MDR Text Key: 117005595
• Report Number: 1423537-2018-00234
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10630140169700
• UDI-Public: 10630140169700
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Device Lot Number: 121616
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1