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

Catalog Number	405672
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0205 - packaging problem patient problem code: f27 ¿ no patient involvement.
Event or Problem Description
Mat#: 405672.Batch#: 0001515524.It was reported by customer that there was tear in the internal packaging of the tray.Verbatim: tear in the internal packaging of the tray.Additional information: (b)(6) 2023.Date of event: (b)(6) 2023; facility name: xxx ; facility address: xxxx.How many occurrences of defective set(s) affected?: one.Was issue being described noted before, or during used?: before.Noticed when outer packaging was opened.Was there any patient involvement?: no.Any adverse events or serious injury reported to patient or healthcare professional?: no.What was the patient outcome? nothing negative was there any delay of, or change in, the course of treatment due to this event? delay as took time to get another spinal tray.What procedure was being performed?: left total knee.What medication was used in the procedure?: bupivacaine from tray.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: two photos were provided to our quality team for investigation.Through visual inspection, a tear in the wrap was observed, verifying the reported incident.There was no evidence of any holes noted in the external packaging.A review of the internal manufacturing device records and raw material history files for reported lot 0001515524 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.Based on the quality team's investigation, we cannot identify a root cause related to our manufacturing process at this time.Manufacturing personnel have been notified of this incident to increase awareness.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
Mat#: 405672; batch#: 0001515524.It was reported by customer that there was tear in the internal packaging of the tray.Verbatim: tear in the internal packaging of the tray additional information: 17oct2023 date of event: 10/10/2023.How many occurrences of defective set(s) affected? one.Was issue being described noted before, or during used? before.Noticed when outer packaging was opened.Was there any patient involvement? no.Any adverse events or serious injury reported to patient or healthcare professional? no.What was the patient outcome? nothing negative.Was there any delay of, or change in, the course of treatment due to this event? delay as took time to get another spinal tray.What procedure was being performed? left total knee.What medication was used in the procedure? bupivacaine from tray.

• 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): 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: 17956856
• Report Number: 1625685-2023-00104
• Device Sequence Number: 5282717
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: (01)00382904056728
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 07/31/2024
• Device Catalogue Number: 405672
• Device Lot Number: 0001515524
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown