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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD DURASAFE¿ TRAY; ANESTHESIA CONDUCTION KIT
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BD (SUZHOU) BD DURASAFE¿ TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401622
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: unknown.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 foreign matter was found in the bd durasafe¿ tray.The following information was provided by the initial reporter, translated from chinese: "opened the package and found impurities in the box".
 
Event Description
It was reported that foreign matter was found in the bd durasafe¿ tray.The following information was provided by the initial reporter, translated from chinese: "opened the package and found impurities in the box.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-oct-2022.Investigation summary a device history review was conducted for lot number 2048492.Our records show that this is the only instance of foreign matter 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 the sample submitted by the facility was reviewed by our quality engineers, who determined that the identity of the foreign matter was hair from the clothing of one of our operators.
 
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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 Key15649410
MDR Text Key307069699
Report Number3014704491-2022-00503
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 11/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number2048492
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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