• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381467
Device Problems Retraction Problem (1536); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2017
Event Type  malfunction  
Manufacturer Narrative
Results: bd received five (5) samples from the customer facility for evaluation by our quality engineer team. All five packages were open at both ends of the blister pack. The packages were analyzed under uv light, as the adhesive used is uv fluorescent. The uv analysis revealed an adequate of top web adhesive. A functionality test was performed and the needle was retracted successfully upon depression of the button. No mechanical/physical evidence to the product was found that could contribute to needle retraction failure. Although the defect of package seal integrity poor was confirmed, there was no physical evidence to confirm or to support manufacturing process related issues for the defect, therefore a root cause could not be determined. Proper personnel have been notified of these reported issues. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Conclusion: the defect package seal integrity poor/questionable, as stated as the reported coded was confirmed with the returned unit. Even though the packages came partially opened, all the processes characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification. No abnormalis were found. The defect of needle retraction failure as stated as the reported coded was not confirmed with the returned units. No physical mechanical evidence was found to trigger the failure and the unit successfully retracted upon activation of the white button. The root cause is indeterminate. Capa 48637 has been opened to address the markings on the washers.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7089383
MDR Text Key266361144
Report Number1710034-2017-00433
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814672
UDI-Public30382903814672
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 12/23/2017
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 Date04/30/2019
Device Catalogue Number381467
Device Lot Number6119986
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 Received11/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2016
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
-
-