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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 WINGED SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 381534
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that bd insyte¿ autoguard¿ winged shielded iv catheter split.The following information was provided by the initial reporter: "material no: 381534, batch no: 0176001.It was reported that: customer stated iv catheter sheared away from iv needle.Event description per phone call states: (b)(6) 2020 9:48 am cst - customer stated iv catheter sheared away from iv needle; no injury to customer/staff or patient.Customer has physical sample available to return for investigation.Questions/inquiries:".
 
Event Description
It was reported that bd insyte¿ autoguard¿ winged shielded iv catheter split.The following information was provided by the initial reporter: "material no: 381534, batch no: 0176001.It was reported that: customer stated iv catheter sheared away from iv needle.Event description per phone call states: (b)(6) 2020 9:48 am cst - customer stated iv catheter sheared away from iv needle; no injury to customer/staff or patient.Customer has physical sample available to return for investigation.Questions/inquiries:".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-10.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one retracted unit along with its original packaging.A visual inspection of the catheter tubing was performed.It was observed that damage to the catheter tubing just above the nose of the adapter was present.A microscopic investigation of the damage was performed.The damage observed to the catheter has the characteristic v shape from the needle piercing through the catheter wall.The reported issue was confirmed as ¿needle through catheter¿.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.The defect could originate during manufacturing processes due to alignment of the set together station, bent tubing, or air blow inconsistency.This type of defect may also originate due to improper use while breaking tip adhesion or while attempting venipuncture by moving the cannula up and down the catheter tubing.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
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Brand Name
BD INSYTE AUTOGUARD WINGED SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key11072443
MDR Text Key226005026
Report Number1710034-2020-00828
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903815341
UDI-Public30382903815341
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2023
Device Model Number381534
Device Catalogue Number381534
Device Lot Number0176001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/24/2020
Supplement Dates Manufacturer Received03/18/2021
Supplement Dates FDA Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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