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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 Complete Blockage (1094)
Patient Problem Insufficient Information (4580)
Event Date 06/22/2022
Event Type  malfunction  
Event Description
It was reported when using the epidural catheter from bd durasafe¿ tray that the catheter was clogged during use.The following was reported by the initial reporter (translated from chinese): the purchasing teacher reported that when the product was used for the patient, it was found that the front end of the epidural catheter was attached to the wall, resulting in the inability of the liquid to flow out after the catheter was placed.
 
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 when using the epidural catheter from bd durasafe¿ tray that the catheter was clogged during use.The following was reported by the initial reporter (translated from chinese): the purchasing teacher reported that when the product was used for the patient, it was found that the front end of the epidural catheter was attached to the wall, resulting in the inability of the liquid to flow out after the catheter was placed.
 
Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 1312059.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 a sample was submitted to aid in our investigation.Our engineers noted that the device was returned in an opened packaging unit and displayed a large kink near the tip of the indwelling catheter.The issue has been confirmed.
 
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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 Key15089950
MDR Text Key304525056
Report Number3014704491-2022-00297
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 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number1312059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2021
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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