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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¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381467
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: received one iag 14ga unit from lot number 5043918. Observed the unit was partially open at one end. 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. Functional test (needle retraction): 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. The key variables that affect seal strength are: seal transfer/width and top web glue. Both of these variables were looked at during the investigation. 5043918¿a total of (b)(4) unit were manufactured on afa line 6 feb 2, 2015 to feb 27, 2015 and packaged on afa packaging line 11 from mar 1, 2015 to mar 2, 2015. In process samples (included but not limited) non-retraction, damaged parts, activation (press button) as well as for blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications. No significant issues were found during the review of the device history record. Conclusions: the defect of package seal integrity, as stated in the event description was confirmed with the returned unit. Even though the packages came partially opened, all the processes characteristics that directly influence the seal strength were observed to be within specification. No anomalies were found. The defect of shield damaged-defective could not be confirmed, no physical mechanical evidence was found to trigger the failure and the unit successfully retracted upon activation of the white button. Package seal integrity: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect. Shield damage defective (needle retraction failure): 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. The customer experience was confirmed based on the evaluation that was performed on the returned units although an absolute root cause cannot be determined.
 
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 several bd insyte autoguard shielded iv catheter(s) experienced a sterile breach (¿package spontaneously opening¿). It was also reported that resistance occurred when using the safety mechanism and the needle doesn¿t retract fully. There was no report of injury or medical interventions.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR 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 Key7089310
MDR Text Key263181520
Report Number1710034-2017-00429
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K952861
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 12/22/2017
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 Date02/28/2018
Device Catalogue Number381467
Device Lot Number5043918
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 Manufactured02/12/2015
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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