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

Model Number	405672
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the tray spn whit25g3.5 l/b-d/e blue drape was ineffective, and the treatment failed to work.The following information was provided by the initial reporter: there were several consecutive failed spinal anesthetics on ob.Consistent factor has been using the spinal bupivacaine (0.75%) from the kits.
Event or Problem Description
It was reported that the tray spn whit25g3.5 l/b-d/e blue drape was ineffective, and the treatment failed to work.The following information was provided by the initial reporter: there were several consecutive failed spinal anesthetics on ob.Consistent factor has been using the spinal bupivacaine (0.75%) from the kits.
Additional Manufacturer Narrative
H6: investigation summary: one sample was provided to our quality team for investigation.The anesthetic ampules and contents were examined.No discernible haze or particulate matter was observed.The samples appeared clear, colorless and did not contain any coloration or hue and had the appearance of water.The returned samples met the criteria for passing, therefore the reported failure was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001387936 was performed and no recorded quality problems or rejections related to this incident were found.The sterilization records indicated no issues.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.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• 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: 12475278
• Report Number: 2243072-2021-02320
• Device Sequence Number: 4739471
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• 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): 02/18/2022

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 Expiration Date: 12/31/2021
• Device Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: 0001387936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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