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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 381812
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/24/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that there was a mix of product with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: after opening the number 24 intravenous device box, we see a different color device (apparently number 22).
 
Event Description
It was reported that there was a mix of product with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, translated from portuguese to english: after opening the number 24 intravenous device box, we see a different color device (apparently number 22).
 
Manufacturer Narrative
H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0027243, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that a 24 gauge and a 22 gauge unit were packaged together.Based off the provided photo the engineer was able to verify the reported failure mode.It was determined that this was most likely an operator error that occurred during the packaging process.A training was issued to all packaging personnel to raise awareness of this issue and prevent recurrence.
 
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Brand Name
BD INSYTE AUTOGUARD SHIELDED 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
MDR Report Key10538702
MDR Text Key209174711
Report Number9610048-2020-00126
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818129
UDI-Public00382903818129
Combination Product (y/n)N
PMA/PMN Number
NA
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 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2022
Device Model Number381812
Device Catalogue Number38181214
Device Lot Number0027243
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/24/2020
Initial Date FDA Received09/15/2020
Supplement Dates Manufacturer Received08/24/2020
Supplement Dates FDA Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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