MAUDE Adverse Event Report: BECTON DICKINSON TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E; ANESTHESIA CONDUCTION KIT

Model Number	406047
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is hdq us (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 tray epid cont we18g3.5 c20 lor5 s/l/l-e experienced needle hub holes.The following information was provided by the initial reporter: this week we had two connectors in your epidural kit that had a hole in the side.Ok both instances we were able to break open another type of kit and use theirs, but i wanted to let you know.
Event or Problem Description
It was reported that 2 tray epid cont we18g3.5 c20 lor5 s/l/l-e experienced needle hub holes.The following information was provided by the initial reporter: this week we had two connectors in your epidural kit that had a hole in the side.Ok both instances we were able to break open another type of kit and use theirs, but i wanted to let you know.
Additional Manufacturer Narrative
H6: investigation summary one photo was provided to our quality team for investigation.Based on the provided photo, the reported failure was not confirmed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.

• Brand Name: TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12303506
• Report Number: 2243072-2021-02040
• Device Sequence Number: 11754965
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: Other
• Device Model Number: 406047
• Device Catalogue Number: 406047
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown