MAUDE Adverse Event Report: BECTON DICKINSON BD PERISAFE¿ EPIDURAL MINI-KIT; ANESTHESIA CONDUCTION KIT

Model Number 400273

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2021

Event Type  malfunction  

Event Description

It was reported 60 bd perisafe¿ epidural mini-kits had deformed tubing.The following information was provided by the initial reporter: "after removing such problematic catheters, kinked catheter tubes are always noticeable.".

Manufacturer Narrative

Investigation summary: there was no sample available but 1 photo was provided to bd for evaluation.Upon review of the photo, bd was able to confirm the reported issue.A review of the device history record was performed and no quality issues were found during production.Possible root cause is due to handling issues as this kind of failure may occur during use.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.At this time a capa is not needed.

• Brand Name: BD PERISAFE¿ EPIDURAL MINI-KIT
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13232545
• MDR Text Key: 286342329
• Report Number: 2243072-2021-03104
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 1155458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1