MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA CONDUCTION KIT

Catalog Number	405671
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 405671 ; batch#: 0001558421.It was reported by customer that local anesthetic potency, during administration the product was not working all the product was administered from the vial.None left.Pt harm: no.Additional information: please see below.This is the email from the physician.This is all the information i have.I'm one of the anesthesiologists working in ob today (b)(6) 2024.We did spinal for c-section today using bupivacaine from the lot number 0001558421.The spinal was done by a srna student under my supervision.The spinal was uneventful and successfully placed.Spinal fluid was visualized prior to dosing and at the end of dosing.However, the patient did not get a good spinal blockade, and we had to repeat the procedure with bupivacaine from a different spinal kit from a different lot.The second spinal was successful and we were able to do the procedure under spinal anesthesia.
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.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001558421 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.We reviewed our sterilization records; no issues were identified during the sterilization process.The certification of analysis, provided to bd by the supplier has been reviewed for the reported lot, all testing done by the supplier verifies the product passed required inspections and is authorized for use.Based on the available information we are not able to identify a root cause related to our process that could impact the efficacy of the medication provided within our kits.The medication within the kit is provided by a supplier.We have notified the supplier of this incident.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 SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
• 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: 20492921
• Report Number: 1625685-2024-00113
• Device Sequence Number: 14341138
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711(11)240311(17)260131(10)0001558421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/04/2024

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: 01/31/2026
• Device Catalogue Number: 405671
• Device Lot Number: 0001558421
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown