MAUDE Adverse Event Report: BECTON DICKINSON TRAY EPID SST18G3.5 S/L; ANESTHESIA CONDUCTION KIT

Catalog Number	406069
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 406069, batch # unknown.It was reported by customer that holes or tears in drape when opening the sterile tray verbatim: holes or tears in drape when opening the sterile tray.This has occurred with a few different trays.The drapes were used, but no pt injury or adverse event.1.Can you please provide an exact date of event in this format mm-dd-yyyy? 05-08-2025.2.Can you please provide the lot number associated with reported issue? unfortunately, we are not certain this may have been the same lot # as the trays with drape holes/tears.We receive several cases every other day.Lot #0001611311.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that the reported event was not reportable to the fda as it is not likely to cause or contribute to serious injury or death.If we receive any information that changes this decision, another follow up mdr will be submitted.Mfr# 1625685-2025-00045 void.
Event or Problem Description
No additional information.

• Brand Name: TRAY EPID SST18G3.5 S/L
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22059928
• Report Number: 1625685-2025-00045
• Device Sequence Number: 7812493
• Product Code: CAZ
• UDI-Device Identifier: 00382904060695
• UDI-Public: (01)00382904060695
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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 Catalogue Number: 406069
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown