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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383323
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.(b)(6).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 was reported that bd saf-t-intima¿ iv catheter safety system was defective.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿the catheter bezel came with problem.".
 
Manufacturer Narrative
H.6.Investigation: a device history review was conducted for lot number 6294176.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 bd saf-t-intima¿ iv catheter safety system was defective.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿the catheter bezel came with problem.".
 
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Brand Name
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MDR Report Key8453760
MDR Text Key140140232
Report Number9610847-2019-00247
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833239
UDI-Public30382903833239
Combination Product (y/n)N
PMA/PMN Number
K013800
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 04/03/2019
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 Date12/31/2021
Device Catalogue Number383323
Device Lot Number7349718
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/11/2019
Initial Date FDA Received03/26/2019
Supplement Dates Manufacturer Received03/11/2019
Supplement Dates FDA Received04/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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