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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38831214
Device Problem Material Twisted/Bent (2981)
Patient Problem Pain (1994)
Event Date 10/19/2022
Event Type  malfunction  
Event Description
It was reported that the tip of the bd insyte¿ iv catheter bent during the infusion.The following information was provided by the initial reporter, translated from portuguese: "peripheral catheter presents resistance when being removed from the skin causing pain to the patient, at the end of the procedure it was observed that the tip had bent.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h10.
 
Event Description
It was reported that the tip of the bd insyte¿ iv catheter bent during the infusion.The following information was provided by the initial reporter, translated from portuguese: "peripheral catheter presents resistance when being removed from the skin causing pain to the patient, at the end of the procedure it was observed that the tip had bent.".
 
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Brand Name
BD INSYTE¿ IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16383655
MDR Text Key309639311
Report Number9610048-2023-00010
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number38831214
Device Lot Number2178661
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2022
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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