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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 INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382534
Device Problems Device Operates Differently Than Expected (2913); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
Event Type  malfunction  
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 the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly, leaving the needle exposed. There was no report of injury or medical interventions.
 
Manufacturer Narrative
Investigation summary: device/batch history record review: dhrs are available for review as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable. Findings: although a dhr review it required for this mdr complaint, review was not conducted because a lot number was not provided for this incident. Sap (qn) database review: no. Reason: this database tracks any issue during production that would affect product quality. Findings: subject code was an s1 severity ranking. Review was not conducted for this mdr- level a investigation, because a lot number was not provided for this incident. Analysis of peura and/or fmea conducted by qe: the peura (end user risk analysis) rm5835 rev 12 version j was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. Visual analysis: observations and testing: observations and testing could not be performed because units were not received for investigation of this incident. Investigation samples(s) meet manufacturing specifications: unknown; units were not received for observation and testing. Investigation conclusion: root cause is indeterminate. Comment: units not provided for investigation of the incident stated in the pir.
 
Event Description
It was reported that the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly, leaving the needle exposed. There was no report of injury or medical interventions.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7602862
MDR Text Key111697711
Report Number1710034-2018-00288
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825340
UDI-Public30382903825340
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382534
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1
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