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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 381423
Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans. Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product. The peura (end user risk analysis) was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. Samples were received for evaluation by our quality engineer team. They received 11 unused iag 22ga units in sealed packages from the lot number 7261882. The actual unit described in the incident report was not returned for evaluation. Visual/microscopic examination showed there was no mechanical/physical damage to any of the components (spring, needle hub, or grips) or evidence of adhesive on the buttons or hubs. Functional test (needle retraction) was performed and showed the retraction was successful, no delayed reaction was observed. The returned units provided for evaluation met and performed per the required manufacturing specifications. As there was no definite physical or mechanical evidence that supported manufacturing process related issues for the defect observed in this incident, a root cause could not be determined. The defect needle retraction failure; as stated as the reported code was not confirmed with the returned unit. The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced, per the pir. A formal corrective action will not be initiated at this time. A manufacturing related root cause could not be identified. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 during use, a bd insyte¿ autoguard¿ shielded iv catheter malfunctioned as the product was found "difficult to retract easily or if at all". There was no report of injury or medical intervention reported.
 
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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 Key7144163
MDR Text Key268247268
Report Number1710034-2017-00493
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814238
UDI-Public30382903814238
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2020
Device Catalogue Number381423
Device Lot Number7261882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2017
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: 12/22/2017 Patient Sequence Number: 1
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