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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 382554
Device Problems Retraction Problem (1536); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2017
Event Type  malfunction  
Manufacturer Narrative
Results - bd received one sample from the customer. Observed the unit was partially open at both ends. No mechanical/physical damage was observed to the spring, needle hub or grip. There were no missing components or evidence of glue on the button or hub. The needle cover was removed, manually rotated the catheter tip 360 degrees, the catheter tubing did not ¿candy canned¿. The white button was depressed and the needle did retract, meeting no resistance. Retraction was successful. The product characteristics require a minimum of 1/8¿ seal transfer. This characteristic was met. In addition the paper top web of the returned unit was analyzed under uv light. The glue used to seal the top and bottom webs is uv fluorescent. The analysis revealed an adequate of top web adhesive. A review of the device history record revealed no significant irregularities during the manufacture of the reported lot. Conclusion - the returned representative unit did not display any adverse characteristics that would contribute to the defect the customer experienced. The defect described in the event description could not be confirmed or replicated with the returned representative unit. The actual unit described in the incident report was not returned for evaluation.
 
Manufacturer Narrative
(b)(6). 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 that the bd insyte¿ autoguard¿ bc shielded iv catheter was opened and unsealed prior to use. Reporter also states retraction failure. No serious injuries or medical intervention noted.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7089494
MDR Text Key258176624
Report Number1710034-2017-00437
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
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 Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2018
Device Catalogue Number382554
Device Lot Number5121690
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
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: 12/06/2017 Patient Sequence Number: 1
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