Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD DURASAFE¿ TRAY; ANESTHESIA CONDUCTION KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD (SUZHOU) BD DURASAFE¿ TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401622
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported that air leakage was found in the bd durasafe¿ tray packaging unit before use.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, air leakage was found after unpacking and the package could not be used".
 
Manufacturer Narrative
Initial reporter e-mail: unknown.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 air leakage was found in the bd durasafe¿ tray packaging unit before use.The following information was provided by the initial reporter, translated from chinese: "in the department of anesthesiology, air leakage was found after unpacking and the package could not be used".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 05-nov-2022.H6: investigation summary a device history review was conducted for lot number 1104994.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.Additionally, samples have been received by our facility for this complaint.Our engineers have reviewed the returned units and found the packaging to be undamaged, the seals intact, and the application of glue adequate and within product specifications.Unfortunately, without the ability observe the reported non-conformance our engineers could not determine a root cause for this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD DURASAFE¿ TRAY
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15666461
MDR Text Key307096209
Report Number3014704491-2022-00514
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904016227
UDI-Public(01)00382904016227
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K012584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number1104994
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-