MAUDE Adverse Event Report: BD DURASAFE¿ TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 401622

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: in response to the event reported a device history review was conducted for lot number 9261538.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Investigation conclusion: unconfirmed: bd was not able confirm the customers indicated failure as no samples or photos were returned, and the retention samples performed within specifications.Root cause description: unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Rationale: the severity is s2.(b)(4).No need for capa.

Event Description

It was reported that the syringe connected to the bd durasafe" tray anesthesia spinal needle leaked medication.This occurred 200 separate times during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when using the anesthesia kit, it was found that the syringe was connected to the spinal anesthesia needle to inject the medicine leaking.After the hospital department staff tested it with a syringe of other brand, no leakage was found.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9261538.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.See h.10.

Event Description

It was reported that the syringe connected to the bd durasafe¿ tray anesthesia spinal needle leaked medication.This occurred 200 separate times during use.The following information was provided by the initial reporter, translated from chinese to english: "when using the anesthesia kit, it was found that the syringe was connected to the spinal anesthesia needle to inject the medicine leaking.After the hospital department staff tested it with a syringe of other brand, no leakage was found.".

• Brand Name: BD DURASAFE¿ TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11101802
• MDR Text Key: 227970654
• Report Number: 3006948883-2020-01071
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 9261538
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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