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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 383312
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
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 when using the bd saf-t-intima iv catheter safety system there was foreign matter on the device needle.The following information was provided by the initial reporter.The customer stated: "when the package was opened there were yellow hairs on the needle tip.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for evaluation?: yes.D.9.Returned to manufacturer on: 11/8/2021 h.6.Investigation: bd received 2 samples submitted for evaluation.The reported issues of foreign matter was observed upon inspection of the samples.The material found at the tip of the catheter is excess silicone lubricant that is applied to the catheter during production.However, this material does not fall under our definition of foreign matter since the material is a part of our manufacturing process.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported when using the bd saf-t-intima iv catheter safety system there was foreign matter on the device needle.The following information was provided by the initial reporter.The customer stated: "when the package was opened there were yellow hairs on the needle tip.".
 
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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
MX 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12865658
MDR Text Key285747674
Report Number9610847-2021-00569
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903833122
UDI-Public00382903833122
Combination Product (y/n)N
Reporter Country CodeCH
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 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383312
Device Lot Number1021359
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2021
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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