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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVENOUS CATHETER
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BD (SUZHOU) BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVENOUS CATHETER Back to Search Results
Catalog Number 383318
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 5 of the safety mechanism falls off the bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: the safety mechanism to prevent needle stick injury comes off when needle is engaged/withdrawn from client.
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 2048726.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately 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 5 of the safety mechanism falls off the bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: the safety mechanism to prevent needle stick injury comes off when needle is engaged/withdrawn from client.
 
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Brand Name
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of Device
INTRAVENOUS CATHETER
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 Key16234037
MDR Text Key308843327
Report Number3014704491-2023-00003
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K013800
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 02/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383318
Device Lot Number2048726
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2022
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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