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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 381433
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: dhr review was performed on the following lot number: 6237829 per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans. Per review qn 200655029 was issued for excessive gel which could contribute to needle retraction failure, but was not related to this incident. Visual analysis observations and testing: received one used iag 22ga unit in an opened package from the lot number 6237829. The unit consisted of the needle safety barrel assembly and needle cover. Visual/microscopic examination: observed the needle was partially retracted into the safety barrel leaving the needle tip exposed. Observed damage on the grip; inward causing the partial retraction. The damage was in the area at the bottom of the grip where it connects to the barrel. Functional test (needle retraction) was performed: the needle was pushed and repositioned to the out position. The button was depressed. The retraction was unsuccessful. The returned used unit provided for evaluation displayed a damaged grip; which inhibited the needle from retracting. Investigation conclusion: the defect needle retraction failure; as stated as the reported code was confirmed with the returned used unit. The returned unit displayed damage to the grip component. This damage inhibited a full retraction of the needle into the barrel upon activation. The customer experienced was confirmed based on the evaluation and testing that was performed on the returned unit. Reproduction of the customer¿s experience was achieved with the testing that was performed on the returned unit. Was the device used for treatment or diagnosis? treatment. Root cause description: relationship of device to the reported incident. Manufacturing comment: the plug probe and the load barrel stations in zone 5 have the ability to become misaligned and produce the type of damage observed in the returned sample. When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint.
 
Event Description
Hold for so 1-10-2018 it was reported that the bd insyte¿ autoguard¿ shielded iv catheter failed to retract after use. No serious injury or medical intervention noted.
 
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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 Key7172345
MDR Text Key96847620
Report Number1710034-2017-00509
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903814336
UDI-Public00382903814336
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
Report Date 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2019
Device Catalogue Number381433
Device Lot Number6237829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
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: 01/08/2018 Patient Sequence Number: 1
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