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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 Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2017
Event Type  malfunction  
Manufacturer Narrative
Date received by manufacturing: changed/corrected from 11/27/2107 to 11/27/2017.
 
Manufacturer Narrative
The customer returned 411 representative units for evaluation. Our quality engineer visually inspected the returned units and was unable to identify any damage to any of the components. Pull testing was then performed and each unit met manufacturing standards. Puller/stylet (pull test) average: 10. 48 pounds; minimum: 6. 60 pounds; maximum: 13. 49 pounds. Specification: 2. 7 pounds (minimum). Having found no values out of specification, we were not able to associate the reported defect to the manufacturing process. A dhr for lot number 7144554 was reviewed and no qns or other events were related to the complaint stated by the customer. A manufacturing review revealed that no equipment, instrument, process and/or surfaces that could cause this kind of damage were detected. Conclusion: with the information provided by the customer and the results obtained in the evaluation of representative samples, we cannot determine the root cause. No capa was opened since this issue could not be confirmed as manufacturing related.
 
Manufacturer Narrative
Date of event: unknown. 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 during use of the bd saf-t-intima¿ iv catheter safety system the assembly that pulls the stylet broke apart, the heplock type port popped right off on a few recent starts. There was no report of injury or medical intervention.
 
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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
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7129219
MDR Text Key256088085
Report Number9610847-2017-00192
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2021
Device Catalogue Number383323
Device Lot Number7144554
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1
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