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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 Device Operates Differently Than Expected (2913)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/17/2018
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 the stylet separating. It was stated ¿the safe t intima inserted into patient. No obvious error or issue with product at the time of insertion. On removing cannula from patient, it was noted that the needle was still in the plastic sheath and had remained present in the patient for the 24 hours. No change to patient care. ¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: one partial unit was received for analysis. Our quality engineer visually inspected the returned unit and confirmed that the needle was broken at the notch. We were unable to confirm the damage to the manufacturing process. Device history and quality records have been consulted for tracking and trending purposes and no issues like this are detected which means low occurrence. Product is functional tested in the manufacturing process, no incidents with separation stylet/needle has been reported. No corrective action required at the failure. Process was reviewed and there are proper controls in place to detect product malfunctions. Based on investigation results to date root cause cannot be determined. No capa was opened since this issue could not be confirmed as manufacturing related.
 
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Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MDR Report Key7447483
MDR Text Key106387699
Report Number9610847-2018-00117
Device Sequence Number1
Product Code FOZ
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 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2021
Device Catalogue Number383323
Device Lot Number7083683
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/20/2018 Patient Sequence Number: 1
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