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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. ANESTHESIA 17GAX18CM DURASAFE CATHETER CONNECTOR
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. ANESTHESIA 17GAX18CM DURASAFE CATHETER CONNECTOR Back to Search Results
Catalog Number 401622
Device Problems Component Incompatible (1108); Misconnection (1399)
Patient Problem No Information (3190)
Event Date 04/10/2019
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 anesthesia 17gax18cm durasafe experienced incompatible components. The following information was provided by the initial reporter: after opening the unit package, it was found that the epidural catheter connector could not be connected with the sip tip syringe. Opening one new product,the new epidural catheter connector can connected to the sip tip syringe.
 
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Brand NameANESTHESIA 17GAX18CM DURASAFE
Type of DeviceCATHETER CONNECTOR
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8555288
MDR Text Key145113286
Report Number3006948883-2019-00306
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot Number8232453
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2019 Patient Sequence Number: 1
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