MAUDE Adverse Event Report: BECTON DICKINSON TRAY SUPPORT 18GSB; ANESTHESIA CONDUCTION KIT

Catalog Number	406060
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
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 #: 406060 batch#: 0001550344 it was reported by customer that while opening trays for pain procedures, 3 of them had holes/tears in the wrapping.Verbatim: while opening trays for pain procedures, 3 of them had holes/tears in the wrapping.New trays were gathered and used.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: three samples were provided to our quality team for investigation.Through visual inspection, a tear in the wrap within the tray was observed on two of the samples.It was noted that the wrap was caught within the seal of the tyvek packaging for one tray, however, it was verified the sterile barrier was in tact, therefore there was no breach of sterility.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001550344 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.While we cannot identify a direct cause for the tears within the wrap, the wrap noted to be within the tyvek seal is verified to be related to manufacturing.A project has been opened to further evaluate this incident.Manufacturing personnel will be notified and awareness training will be provided.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: TRAY SUPPORT 18GSB
• 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: 19333254
• Report Number: 1625685-2024-00050
• Device Sequence Number: 7004216
• Product Code: CAZ
• UDI-Device Identifier: 00382904060602
• UDI-Public: (01)00382904060602
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 06/30/2026
• Device Catalogue Number: 406060
• Device Lot Number: 0001550344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown