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

Catalog Number 405672

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 325929314
• Report Number: 1625685-2023-00104
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: (01)00382904056728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405672
• Device Lot Number: 0001515524
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1