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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.
 
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.
 
Manufacturer Narrative
Investigation: a device history review was conducted for lot number 8232456 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, our quality engineers reviewed the device provided by your facility, and founded device to be qualified by the standards set by production specifications.Unfortunately without being able to review the reported failure mode, the root cause could not be determined at the conclusion of our review.
 
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Brand Name
ANESTHESIA 17GAX18CM DURASAFE
Type of Device
CATHETER CONNECTOR
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
MDR Report Key8555288
MDR Text Key145113286
Report Number3006948883-2019-00306
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
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 Expiration Date08/31/2023
Device Catalogue Number401622
Device Lot Number8232453
Date Manufacturer Received04/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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