MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. DRESSING CHANGE TRAY CVC; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Model Number 25-2835

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/31/2021

Event Type  malfunction  

Event 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
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.
• MDR Report Key: 12432748
• MDR Text Key: 270488773
• Report Number: MW5103738
• Device Sequence Number: 1
• Product Code: PEZ
• UDI-Device Identifier: 10612479182483
• UDI-Public: (01)10612479182483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR