• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382512
Device Problems Mechanical Problem (1384); Retraction Problem (1536); Device Operates Differently Than Expected (2913)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/16/2016
Event Type  Injury  
Manufacturer Narrative
Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd is not able to duplicate or confirm the customer¿s indicated failure mode. (b)(4).
 
Event Description
It was reported that a nurse obtained a contaminated needle stick injury from a used 24 g x 0. 75 in. Bd insyte¿ autoguard¿ bc shielded iv catheter because the safety activation button jammed and the needle only partially retracted. The nurse washed and cleaned the puncture site and the source patient received post exposure lab work. The test results were negative and no further medical interventions were provided to the nurse or source patient.
 
Manufacturer Narrative
Results: as previously reported, a sample is not available for evaluation. However, on 12/16/2016, the customer provided two photos of the affected device. A photo inspection revealed the needle was partially retracted into the safety barrel leaving the needle tip exposed. Damage was observed on the grip the unit. The damage was facing inward and in the area at the bottom of the grip where it connects to the barrel. Conclusion: our quality engineer has determined that based off of the returned photos, the root cause for this incident is related to the manufacturing process. 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 photos. When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint sample. A formal corrective action will not be initiated at this time. 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. Manufacturing was notified of this incident and the findings.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name24 G X 0.75 IN. BD 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
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 Key6153005
MDR Text Key61697118
Report Number1710034-2016-00059
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
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 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number382512
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/07/2016 Patient Sequence Number: 1
-
-