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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHILEDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHILEDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2017
Event Type  malfunction  
Manufacturer Narrative
Supplemental for correction of bd awareness date. Initial mdr reported the "date received by manufacturer" as 08/28/17 but should have been reported as 08/21/2017.
 
Manufacturer Narrative
Investigation: received one (1) iag used unit from an unknown lot number, the unit consisted of a needle/barrel assembly and a needle cover. The unit was received with the needle entirely out of the safety barrel and the white button was not pressed, there was no damage observed to the spring, needle hub or grip and there were no missing components. Traces of blood were visible in the needle hub. Preceded to perform the functional test by pushing the white button, the needle did no retract and the button could not be pushed. Observed there were traces of cured adhesive in between the white button and the grip of the assembly. The defect of needle retraction failure as stated in the subject of the pir was confirmed. Traces of cured adhesive in between the white button and the grip of the assembly prevented the white button from being depressed therefore, the needle did not retract. The cured adhesive observed in between the white button and the grip of the assembly was physical evidence to confirm and support the manufacturing process related issues for the defect.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field.
 
Event Description
It was reported that the safety mechanism on an unspecified bd insyte¿ autoguard¿ shileded iv catheter did not function correctly, leaving the needle exposed. There was no report of injury or medical interventions.
 
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Brand NameUNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHILEDED 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 Key6880067
MDR Text Key251734549
Report Number1710034-2017-00231
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated by Manufacturer? Yes
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: 09/20/2017 Patient Sequence Number: 1
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