MAUDE Adverse Event Report: BECTON DICKINSON BD DURASAFE PLUS EPIDURAL LOCK CSE MINI-KIT; ANESTHESIA KIT (CSE)

Catalog Number 400287

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that in preparation for childbirth the pt was undergoing spinal anesthesia with a bd durasafe plus epidural lock cse mini-kit.While the physician was performing the procedure, he reported that there was a reflux of blood due to possible puncture of a blood vessel.He injected the pt with lidocaine to control the bleeding then pulled out the needle and catheter.As he did so, he felt that the catheter had broken,.The physician then used a second bd durasafe plus kit and successfully anesthetized the pt.After childbirth the pt had an x-ray, ct scan, and an mri to locate the broken catheter.The broken catheter was not visualized on any of the imaging studies.The pt was also evaluated by a neurosurgeon.The physician concluded his report that the pt is well.

Manufacturer Narrative

A sample is available for eval.Once the sample is received it will be evaluated and upon completion of the investigation, a supplemental report will be submitted.(b)(4).

• Brand Name: BD DURASAFE PLUS EPIDURAL LOCK CSE MINI-KIT
• Type of Device: ANESTHESIA KIT (CSE)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4187717
• MDR Text Key: 5160584
• Report Number: 2243072-2014-00239
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 400287
• Device Lot Number: 3189489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR