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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER Back to Search Results
Model Number 381834
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Event Description
It was reported that the bd insyte autoguard pnk 20ga x 1.16in experienced a needle that would not retract.The following information was provided by the initial reporter: the intravenous catheter safety lock did not work during use.
 
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.The manufacturing facility has been notified of this incident and the findings.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 bd insyte autoguard pnk 20ga x 1.16in experienced a needle that would not retract.The following information was provided by the initial reporter: the intravenous catheter safety lock did not work during use.
 
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Brand Name
BD INSYTE AUTOGUARD PNK 20GA X 1.16IN
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 Key15554296
MDR Text Key306896460
Report Number9610048-2022-00114
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818341
UDI-Public00382903818341
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
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 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381834
Device Catalogue Number38183414
Device Lot Number1300240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2021
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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