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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383005
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Abdominal Pain (1685); Perforation (2001)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that one bd saf-t-intima¿ closed iv catheter system has been found with a damaged catheter before use.The following has been provided by the initial reporter: in order to seek further diagnosis and treatment in our hospital, the outpatient department underwent plain standing radiographs and admitted to our department with "1, gastric perforation 2, and abdominal pain check factor".Since the onset, the spirit and diet have been poor, the stool has not been resolved, and the weight has not changed significantly.Body temperature is 36.9, pulse is 82 beats / min, breath is 20 beats / min, blood pressure is 111 / 78mmhg.The closed indwelling needle was used before the operation, and the needle catheter was found to be bifurcated.The indwelling needle was immediately replaced with a new one, and the patient's condition continued to be observed.This event did not affect the patient's physical and mental health, and there was no combined use of this event.
 
Manufacturer Narrative
H.6.Investigation summary: a device history review was conducted for lot number 8326608.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.Bd will continue to monitor this issue.
 
Event Description
It has been reported that one bd saf-t-intima¿ closed iv catheter system has been found with a damaged catheter before use.The following has been provided by the initial reporter: in order to seek further diagnosis and treatment in our hospital, the outpatient department underwent plain standing radiographs and admitted to our department with "1, gastric perforation 2, and abdominal pain check factor".Since the onset, the spirit and diet have been poor, the stool has not been resolved, and the weight has not changed significantly.Body temperature is 36.9, pulse is 82 beats / min, breath is 20 beats / min, blood pressure is 111 / 78mmhg.The closed indwelling needle was used before the operation, and the needle catheter was found to be bifurcated.The indwelling needle was immediately replaced with a new one, and the patient's condition continued to be observed.This event did not affect the patient's physical and mental health, and there was no combined use of this event.
 
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Brand Name
BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM
Type of Device
CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
MDR Report Key9540538
MDR Text Key181442824
Report Number3006948883-2019-01159
Device Sequence Number1
Product Code FOZ
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,other,user facility
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/22/2022
Device Catalogue Number383005
Device Lot Number8326608
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received01/02/2020
Supplement Dates Manufacturer Received12/17/2019
Supplement Dates FDA Received02/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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