MAUDE Adverse Event Report: DRESSING CHANGE TRAY CVC; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Model Number	25-2835
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
My nurse opened the mckesson dressing change tray cvc package and as we pulled out the sterile field a dead bug fell out from inside the sterile field drape.The sterile package seals were intact with no evidence of damage to the package or contents.Lot #282645.Expiration 2023-08-05.Mfr #25-2835.Fortunately an additional dressing change kit was available and used due to suspected compromise of cleanliness and sterility of package materials.Fda safety report id# (b)(4).

• Brand Name: DRESSING CHANGE TRAY CVC
• Common Device Name: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• MDR Report Key: 12432748
• Report Number: MW5103738
• Device Sequence Number: 3651845
• Product Code: PEZ
• UDI-Device Identifier: 10612479182483
• UDI-Public: (01)10612479182483
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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 Expiration Date: 08/05/2023
• Device Model Number: 25-2835
• Device Catalogue Number: 25-2835
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No Information
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 39 YR