MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN WHIT27G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405699
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f2303 - medication required.Device problem code: a0105 - lack of effect.
Event or Problem Description
Material#: 405699.Batch number#: 0001524849.It was reported by customer that having an issue with the spinal trays with the lot #0001524849.It seems that the bupivacaine hcl that is in the tray is the problem.The medication has not been effective in multiple cases between last week and this week leading to patients requiring more medication or even general anesthesia.During our investigation, anesthesia used the bupivacaine stocked in the pyxis vs the bupivacaine from the tray and the anesthesia was effective.Verbatim#: rcc received a complaint via email.Email(s) attached.Reported issue per customer: "we are having an issue with the spinal trays with the lot #0001524849.It seems that the bupivacaine hcl that is in the tray is the problem.The medication has not been effective in multiple cases between last week and this week leading to patients requiring more medication or even general anesthesia.During our investigation, anesthesia used the bupivacaine stocked in the pyxis vs the bupivacaine from the tray and the anesthesia was effective." medline reference: (b)(4).Item: 405699.Quantity affected: (b)(4).Serial/lot number: (b)(6).Po #: (b)(4).Are any samples available for return? yes.
Additional Manufacturer Narrative
Pr 9354640 follow up mdr for device evaluation: forty trays were provided to our quality team for investigation.All returned product belonged to b.Braun, none of the trays were bd products.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001524849 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.The sterilization record was reviewed, no issues were identified.Retain samples were analyzed, per the drug retain visual examination procedure, and no issues were identified.Based on the available information we are not able to identify a root cause at this time.We have notified the supplier of this incident.We appreciate you taking the time to bring this observation to our attention.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
Material#: 405699, batch number#: 0001524849.It was reported by customer that having an issue with the spinal trays with the lot #0001524849.It seems that the bupivacaine hcl that is in the tray is the problem.The medication has not been effective in multiple cases between last week and this week leading to patients requiring more medication or even general anesthesia.During our investigation, anesthesia used the bupivacaine stocked in the pyxis vs the bupivacaine from the tray and the anesthesia was effective.Verbatim#: rcc received a complaint via email.Email(s) attached.Reported issue per customer: "we are having an issue with the spinal trays with the lot #0001524849.It seems that the bupivacaine hcl that is in the tray is the problem.The medication has not been effective in multiple cases between last week and this week leading to patients requiring more medication or even general anesthesia.During our investigation, anesthesia used the bupivacaine stocked in the pyxis vs the bupivacaine from the tray and the anesthesia was effective." medline reference: (b)(4).Item: 405699.Quantity affected: 3 cases.Serial/lot number: (b)(6).Po #: 4516662091.Are any samples available for return? yes.

• Brand Name: TRAY SPN WHIT27G3.5 L/B-D/E
• 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18303162
• Report Number: 1625685-2023-00122
• Device Sequence Number: 6783570
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: (01)00382904056995
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 02/13/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 405699
• Device Lot Number: 0001524849
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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 Sex: Unknown