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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNSPECIFIED BD LUER LOCK; UNSPECIFIED BD¿ LUER LOCK
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNSPECIFIED BD LUER LOCK; UNSPECIFIED BD¿ LUER LOCK Back to Search Results
Catalog Number 381434
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.
 
Event Description
It was reported that an unspecified bd¿ luer lock product are pulling apart at the connection.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: unable to determine a root cause.
 
Event Description
It was reported that an unspecified bd¿ luer lock product are pulling apart at the connection.There was no report of exposure, serious injury or medical intervention.
 
Event Description
It was reported that bd insyte¿ autoguard¿ shielded iv catheter had a defective luer lock which lead to disconnection.Furthermore the disconnection led to an interruption in medication being administered during anesthesia causing the patient to become conscious.
 
Manufacturer Narrative
Event attributed to: corrected to "life threatening".This event has the potential to be life threatening.Describe event or problem: re-written to include further information about the event.Type of reportable events: corrected to "serious injury".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device manufacturer: becton dickinson infusion therapy systems inc.Medical device catalog #: 381434.(b)(4).These details did not change the outcome of the investigation.
 
Event Description
It was reported that bd insyte autoguard shielded iv catheter had a defective luer lock which lead to disconnection.Furthermore the disconnection led to an interruption in medication being administered during anesthesia causing the patient to become conscious.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: life threatening.Device single use?: no.Device returned to manufacture: no.No unit or photos were provided for evaluation and testing.The review of the dhrs could not be performed as the lot number was not provided.Probable root cause is indeterminate ¿ without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.
 
Event Description
It was reported that bd insyte autoguard shielded iv catheter had a defective luer lock which lead to disconnection.Furthermore the disconnection led to an interruption in medication being administered during anesthesia causing the patient to become conscious.
 
Manufacturer Narrative
Awareness date was corrected from (b)(6) 2018 to (b)(6) 2018.
 
Event Description
It was reported that an unspecified bd luer lock product are pulling apart at the connection.There was no report of exposure, serious injury or medical intervention.
 
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Brand Name
UNSPECIFIED BD LUER LOCK
Type of Device
UNSPECIFIED BD¿ LUER LOCK
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7758136
MDR Text Key116867769
Report Number2243072-2018-01036
Device Sequence Number1
Product Code KST
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381434
Device Lot NumberUNKNOWN
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
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