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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: received one used iag/bc 22ga unit from an unknown lot number. The unit consisted of the needle safety barrel assembly and needle cover. Observed the needle was partially retracted leaving the needle exposed and the white button was depressed. Observed the spring was bound. The needle then reassembled to the out position, the button was depressed and the needle retracted fully into the safety barrel. Observed the spring was no longer bound. Although the review of the dhr is required for all mdr per (b)(4), a review could be performed as no lot number was provided for this incident. Conclusions: the defect of needle retraction failure; as stated as the reported code was confirmed with the returned unit. Bound springs are typically caused by a larger od that causes one portion of the spring to become overlapped by another portion of the spring during compression caused by loading the hub.
 
Manufacturer Narrative
Medical device expiration date: unknown. No lot # provided. Device manufacture date: unknown. 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 22 g x 1 in. (1. 3 mm x 30 mm) bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly. There was no report of exposure, injury or medical interventions.
 
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Brand Name22 G X 1 IN. (1.3 MM X 30 MM) 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 Key6984141
MDR Text Key256284189
Report Number1710034-2017-00287
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381023
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2017
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: 10/27/2017 Patient Sequence Number: 1
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