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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2022
Event Type  malfunction  
Event Description
It was reported that during use, the syringe within bd durasafe¿ tray was damaged.The following information was provided by the initial reporter, translated from chinese to english: before using the product in the department of anesthesiology, it was found that the connector of the syringe in the package was deformed and bent, and the part marked with the number of grams was also deformed.
 
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 during use, the syringe within bd durasafe¿ tray was damaged.The following information was provided by the initial reporter, translated from chinese to english: before using the product in the department of anesthesiology, it was found that the connector of the syringe in the package was deformed and bent, and the part marked with the number of grams was also deformed.
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number: 1286013.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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
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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 Key15533166
MDR Text Key306508731
Report Number3014704491-2022-00466
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904016227
UDI-Public(01)00382904016227
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
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 10/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number1286013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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