MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBING, NONINVASIVE

Model Number	N612
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Opened 2 surgical supply packs that were contaminated with debris; both packs discarded.We then just opened up supplies individually forgoing the pack since we had gotten 2 in a row that were contaminated; however when we did that, we did find some suction tubing that did have some debris on it.That was from cardinal health suction tubing lot# l20100122s ref# (b)(4) exp 9/30/2025 as a result of that having debris on it we once again broke down the set up, the patient was not yet in the room.We reopened everything and nothing else appeared to be contaminated.I do have the items and their paperwork with me and i will bring those down to the quality drop off area.Pictures attached of suction tubing packaging and tubing itself.Suction tubing available for return and analysis.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12216869
• Report Number: 12216869
• Device Sequence Number: 1493499
• Product Code: GAZ
• UDI-Device Identifier: 10885380072420
• UDI-Public: (01)10885380072420(17)250930(10)L20100122S
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2021
• Report Date (Section F): 07/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: N612
• Device Catalogue Number: N612
• Device Lot Number: L20100122S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/12/2021