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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 383329
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2018
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 with the use of the bd saf-t-intima¿ iv catheter safety system there was an issue with safety mechanism not covering needle.There was no report of injury or medical intervention.
 
Event Description
It was reported with the use of the bd saf-t-intima iv catheter safety system there was an issue with safety mechanism not covering needle.There was no report of injury or medical intervention.
 
Manufacturer Narrative
A device history review was conducted for lot number 7300685, our records show it was manufactured on november 11, 2017; it was determined that this is the only instance of a needle retraction failure occurring in this lot.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 of packaged goods.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.Therefore, we cannot confirm or associate this complaint to the manufacturing process.Bd will continue to monitor this issue.No corrective action was performed since this issue could not be confirmed as manufacturing related.
 
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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 Key7821358
MDR Text Key118529867
Report Number9610847-2018-00298
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 10/16/2018
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 Date10/31/2021
Device Catalogue Number383329
Device Lot Number7300685
Initial Date Manufacturer Received 08/09/2018
Initial Date FDA Received08/27/2018
Supplement Dates Manufacturer Received08/09/2018
Supplement Dates FDA Received10/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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