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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II; INTRAVASCULAR CATHETER
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383408
Device Problem Leak/Splash (1354)
Patient Problem Ischemia (1942)
Event Date 12/04/2019
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 24g x 0.75in (0.7 x 19 mm) w/ y intima ii experienced leakage prior to use.The following information was provided by the initial reporter: on (b)(6) 2019, due to postcirculative ischemia, the patient was given 250ml normal saline and 400mg puerarin injection.During intravenous infusion, the indwelling needle leakage was found during the examination of indwelling needle, and the indwelling needle was immediately replaced.
 
Manufacturer Narrative
H.6.Investigation:a device history review was conducted for lot number 7019473.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that the 24g x 0.75in (0.7 x 19 mm) w/ y intima ii experienced leakage prior to use.The following information was provided by the initial reporter: on (b)(6) 2019, due to postcirculative ischemia, the patient was given 250ml normal saline and 400mg puerarin injection.During intravenous infusion, the indwelling needle leakage was found during the examination of indwelling needle, and the indwelling needle was immediately replaced.
 
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Brand Name
24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
MDR Report Key9536055
MDR Text Key179941883
Report Number3006948883-2019-01149
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K143610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2020
Device Catalogue Number383408
Device Lot Number7019473
Date Manufacturer Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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