MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ADAPTER

Catalog Number 401622

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that anesthesia 17gax18cm durasafe leaked during use.The following information was provided by the initial reporter: when anesthesiologists used epidural catheters, the medicine was injected after catheterization, there was leakage at the syringe joint of the catheters, it was resulting in the leakage of the liquid and there was the gap of the dose.

Manufacturer Narrative

Investigation summary a device history review was conducted for lot number 9046560.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.

Event Description

It was reported that anesthesia 17gax18cm durasafe leaked during use.The following information was provided by the initial reporter: when anesthesiologists used epidural catheters, the medicine was injected after catheterization, there was leakage at the syringe joint of the catheters, it was resulting in the leakage of the liquid and there was the gap of the dose.

• Brand Name: ANESTHESIA 17GAX18CM DURASAFE
• Type of Device: ADAPTER
• MDR Report Key: 9812566
• MDR Text Key: 188672802
• Report Number: 3006948883-2020-00080
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/02/2024
• Device Catalogue Number: 401622
• Device Lot Number: 9046560
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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): Other