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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401622
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
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 epidural catheter could not connect to the damaged bd durasafe¿ tray adapter during use. The following information was provided by the initial reporter, translated from (b)(6) to english: "the patient entered the operating room for normal anesthesia and puncture catheterization. After catheterization, it was found that the epidural catheter could not be connected to the connector, so he had to abandon this operation and replace the puncture kit for a second time. It does not cause the doctor's work extensively, and at the same time causes secondary injury to the patient, and also increases the risk of secondary injury and medical disputes".
 
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Brand NameBD DURASAFE¿ TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12636835
MDR Text Key281676740
Report Number3014704491-2021-00199
Device Sequence Number1
Product Code CAZ
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 11/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number401622
Device Lot Number9232404
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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