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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 Problems Retraction Problem (1536); Self-Activation or Keying (1557); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2017
Event Type  malfunction  
Manufacturer Narrative
Bd received fourteen sample units were received for evaluation by our quality engineer team. Upon examination, eleven units were open at both ends of the blister pack and three were open at one end of the blister pack. The packages were analyzed under uv light, as the adhesive used is uv fluorescent. The uv analysis revealed an adequate amount of top web adhesive. A functionality test resulted in a successful retraction of the needle, with no signs of mechanical or physical damage that could contribute to the reported issue of needle retraction failure. Although the defect of package seal integrity poor was confirmed, since no physical evidence was found to support manufacturing process related issues, a root cause could not be determined. Proper personnel have been notified of these issues for further review. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. 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 are: seal transfer and top web glue, measured within specification. No anomalies were found. The defect of needle retraction failure 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. Refer to (b)(4). Root cause is indeterminate.
 
Manufacturer Narrative
Initial reporter phone#: (b)(6). Initial reporter fax#: (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 Key7089286
MDR Text Key264957040
Report Number1710034-2017-00428
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 12/27/2017
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 Date01/31/2019
Device Catalogue Number381467
Device Lot Number6042643
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 Manufactured02/12/2016
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
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