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	Pain (1994)
Date of Event	01/31/2024
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.
Event or Problem Description
Material#: (b)(4) lot#: 0001536091, 0001537529 it was reported by the customer reported i am writing regarding spinal trays having medication not working during procedures.Patient is feeling pain.Verbatim: rcc received a complaint via email.Email(s) attached.I am writing regarding spinal trays having medication not working during procedures.Patient is feeling pain.Item# 405671 (bf405671) lot# 0001536091 lot# 0001537529.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation and additional information: following the submission of the initial mdr, additional information was obtained: section b: updated with the additional information received.Section b: adverse event type changed to reflect the serious injury as well.Section h: type of reportable event changed to serious injury.Annex f code updated.Device evaluation: no samples or photos received for investigation.A device history review was performed for lot 0001536091, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The sterilization release record was reviewed for the finished good trays, the requirements for it's release were met.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.We have notified the supplier of this incident.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Additional information: follow-up: customer response on (b)(6) 2024: 1) please provide date of event? i do not have an event date to provide 2) any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? i do not have photos to supply.I did just send it 4 samples to bd which will go out today.3) did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? yes, this happened during patient use.Dr used one tray, then a second but the patient felt pain.Patient then had to be put under anesthesia.Customer response on (b)(6) 2024: 1) were you able to complete the procedures using a different vial of medication? tried two trays and both medications did not work - patient then underwent anesthesia.2) if not, did you need to revert to general anesthesia? yes - see above.3) were the procedures completed? yes.4) please provide date of event? unavailable.5) any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? a label was sent to us yesterday and will ship today.Sending 4 samples to you.6) did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? there was no death or injury.Case was completed using anesthesia.

• 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: 18751784
• Report Number: 1625685-2024-00021
• Device Sequence Number: 15034949
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: 08/31/2025
• Device Catalogue Number: 405671
• Device Lot Number: 0001536091
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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