MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN ANESTHESIA KIT; ANESTHESIA CONDUCTION KIT

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Pr (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.H3 other text : see h10 manufacture narrative.

Event Description

Materials#: unknown batch#: unknown.It was reported by the customer that epidural catheter tip disconnection is on the rise.Verbatim: rcc received a complaint via email.Email(s) attached.Aware date: 24jan2024.Material: unknown bd cse kit.Lot: unknown.Verbatim: 1 epidural catheter tip disconnection is on the rise.2 we do not have smith catheter tip connector & there was one incidence of disconnection.3 epidural catheter placement has been more bloody as compared to arrow kits, we had to switch 3 of the epidural to continuous infusion from intermittent bolus after few flushes, one we had to replace it.None of these were intravascular placement confirmed by test dose & could be flushed manually & continuous worked fine.The epidural catheter which had to be replaced was blood tinged but no bright red blood blocking it.Please see email below from our chief of ob anesthesia.She also texted me last week about post dural puncture headaches and 3 additional connector disconnects.Last week, in response to the concerns, we provided peel pack epidural tuohy needles b braun ref# 332180 and smiths portex ref# 4909e connectors.The team opted not to use the epimed connector ref# 166-1936 because they are able to unlock the mechanism manually with minimal effort.This week the team reported that the b braun tuohy is sharp and incompatible with the bd components (catheter is shearing) and the smiths connector is also disconnecting from the bd catheter.

Manufacturer Narrative

Pr (b)(4) follow up mdr for investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

Event Description

Materials#: unknown batch#: unknown.It was reported by the customer that epidural catheter tip disconnection is on the rise.Verbatim: rcc received a complaint via email.Aware date: 24jan2024.Material: unknown bd cse kit.Lot: unknown.Verbatim: 1 epidural catheter tip disconnection is on the rise.2 we do not have smith catheter tip connector & there was one incidence of disconnection.3 epidural catheter placement has been more bloody as compared to arrow kits, we had to switch 3 of the epidural to continuous infusion from intermittent bolus after few flushes, one we had to replace it.None of these were intravascular placement confirmed by test dose & could be flushed manually & continuous worked fine.The epidural catheter which had to be replaced was blood tinged but no bright red blood blocking it.Please see email below from our chief of ob anesthesia.She also texted me last week about post dural puncture headaches and 3 additional connector disconnects.Last week, in response to the concerns, we provided peel pack epidural tuohy needles b braun ref# 332180 and smiths portex ref# 4909e connectors.The team opted not to use the epimed connector ref# 166-1936 because they are able to unlock the mechanism manually with minimal effort.This week the team reported that the b braun tuohy is sharp and incompatible with the bd components (catheter is shearing) and the smiths connector is also disconnecting from the bd catheter.

• Brand Name: UNKNOWN ANESTHESIA KIT
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18684620
• MDR Text Key: 336407399
• Report Number: 1625685-2024-00016
• Device Sequence Number: 1
• Product Code: CAZ
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1