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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 22 G X 1 IN. INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38182314
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/17/2017
Event Type  malfunction  
Manufacturer Narrative
Results: bd received samples from the customer facility for investigation. The samples were visually examined under magnification and the customer's indicated failure mode for safety shield activation with the incident lot was observed. A review of dhr was completed for the incident lot and no issues were identified. Additionally, a corrective maintenance history review was conducted and no issues were identified. Conclusion: bd was able to confirm the reported failure. Based on the investigation results, no definitive root cause from the manufacturing process was identified as a contributor to the reported failure. Based on an evaluation of severity and frequency, it was determined that no corrective action is required at this time. Complaints received for this device and reported condition will continue to be tracked and trended.
 
Manufacturer Narrative
Medical device expiration date: unknown. Initial reporter phone#: (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. The reported lot # does not exist for the reported catalog #. Therefore, the device manufacturer and expiration dates are unknown.
 
Event Description
It was reported during use of the bd insyte¿ autoguard¿ shielded iv catheter 22 g x 1 the patient was punctured when the safety shield was triggered, patient stated ¿it did not work¿. There was no report of injury or medical intervention.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.
Type of DeviceINTRAVASCULAR 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6996790
MDR Text Key256229046
Report Number9610048-2017-00062
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number38182314
Device Lot Number7151709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
Was Device Evaluated by Manufacturer? Yes
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: 11/02/2017 Patient Sequence Number: 1
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