MAUDE Adverse Event Report: BD (SUZHOU) BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 401622

Device Problem Leak/Splash (1354)

Patient Problems Cerebrospinal Fluid Leakage (1772); Blood Loss (2597)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd durasafe plus¿ epidural lock cse needle set was not tightly connected to the plastic needle, causing leakage of blood and cerebrospinal fluid from the connection between them during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "during the puncturing process, the anesthesia spinal needle and the inner plastic needle were not tightly connected, it caused that the fluid was leaked from the joint of the two needles." "blood and cerebrospinal fluid leaked without contaminating patients or clinical users".

Event Description

It was reported that the bd durasafe plus¿ epidural lock cse needle set was not tightly connected to the plastic needle, causing leakage of blood and cerebrospinal fluid from the connection between them during use.The following information was provided by the initial reporter, translated from chinese to english: "during the puncturing process, the anesthesia spinal needle and the inner plastic needle were not tightly connected, it caused that the fluid was leaked from the joint of the two needles." "blood and cerebrospinal fluid leaked without contaminating patients or clinical users".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 9077573.Our records show that this is the only instance of a leakage 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.Based on through analysis of the provided photograph, our engineers have determined that the leakage occurred due to human factor via an abnormal epoxy application.During the manufacturing process the needle is affixed to the adapter hub using a manual application of epoxy resin; inadvertent over application of the epoxy is currently monitored using microscopic inspection on all finished goods prior to shipment.To mitigate the reoccurrence of this event the inspection team has been retrained on all relevant procedures.

• Brand Name: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10049326
• MDR Text Key: 194650261
• Report Number: 3006948883-2020-00182
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/11/2024
• Device Catalogue Number: 401622
• Device Lot Number: 9077573
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other