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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 WITH WINGS; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER WITH WINGS; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381944
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).
 
Event Description
It was reported that 10 bd insyte¿ autoguard¿ shielded iv catheters with wings were found without labels before use.The following information was provided by the initial reporter, translated from french to english: "catheters didn't have labelling on the primary packaging.It is not possible to identify them.It concerns 10 catheters.".
 
Event Description
It was reported that 10 bd insyte¿ autoguard¿ shielded iv catheters with wings were found without labels before use.The following information was provided by the initial reporter, translated from french to english: "catheters didn't have labelling on the primary packaging.It is not possible to identify them.It concerns 10 catheters.".
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photograph submitted for evaluation.Bd received one photo showing the top web of two units and the bottom web of one unit.A device history record review could not be performed as the lot number is unknown.Through the visual examination the photo revealed that no print was present on the two seal packages with the top web displayed confirming the reported defect.During the manufacturing process a 100% vision inspection is performed and packages that are missing printed information are rejected.Manufacturing personnel then inspect the rejected units and can return acceptable packages.The most likely root cause is due to operator error.
 
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Brand Name
BD INSYTE AUTOGUARD SHIELDED IV CATHETER WITH WINGS
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key10743602
MDR Text Key214799197
Report Number1710034-2020-00683
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381944
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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