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	Twitching (2172)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Material: 405671 batch#: unknown.It was reported by the customer that while surgeon was making incision patient was moving her leg.Surgeon stopped and (b)(6)converted to general.Spinal kit was a bd lot number was more than likely 405671, but not positive.Medication in question is bupivacaine 0.75%.Verbatim: rcc received a complaint via email.Email(s) attached.Crna (certified registered nurse anesthetist) completed spinal without difficulty.While surgeon was making incision patient was moving her leg.Surgeon stopped and (b)(6)converted to general.Spinal kit was a bd lot number was more than likely 405671, but not positive.Medication in question is bupivacaine 0.75%.
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: 405671.Batch#: unknown.It was reported by the customer that while surgeon was making incision patient was moving her leg.Surgeon stopped and (b)(6) converted to general.Spinal kit was a bd lot number was more than likely 405671, but not positive.Medication in question is bupivacaine 0.75%.Verbatim: rcc received a complaint via email.Email(s) attached.Crna (certified registered nurse anesthetist) completed spinal without difficulty.While surgeon was making incision patient was moving her leg.Surgeon stopped and (b)(6)converted to general.Spinal kit was a bd lot number was more than likely 405671, but not positive.Medication in question is bupivacaine 0.75%.
Additional Manufacturer Narrative
Pr (b)(4).Follow up mdr for device evaluation/correction: correction: following submission of initial mdr< it was identified the type of event was incorrectly reported as malfunction.Type of event updated to correctly reflect serious injury.Device evaluation: no physical samples that display the reported condition were available for investigation.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, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• 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: 19689465
• Report Number: 1625685-2024-00068
• Device Sequence Number: 7936149
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405671
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female