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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 22GA 1.00IN; INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381923
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Event Description
It was reported while using bd insyte¿ autoguard¿ winged shielded iv catheter 22ga 1.00in the needle failed to retract.There was no report of patient impact.The following information was provided by the initial reporter: the customer's verbatim report is as follows: (2) the hcp pressed the button, but the needle was not retracted (registered as needle retraction failure).
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 14-apr-2022.H.6.Investigation: our quality engineer inspected sample and photographs submitted for evaluation.Bd received one 22g x 1.00in.Insyte autoguard unit with no documentation to indicate the reference number or lot number.Additionally, four photos were provided for investigation.In the first three photos the unit can be seen in an un-retracted state.The fourth photo shows the same unit with the needle retracted.No media can be seen in any of these photos.The returned unit was similar to the photographed unit; however, black and red media was present inside the grip and barrel.Looking at the provided pictures and the picture taken before decontamination media is not present in those photos.Therefore, it is likely that the media was introduced during the decontamination procedure.Additionally, since three of the provided pictures show the unit in an un-retracted state, it is likely that the unit was not used.Further microscopic inspection found that there was a single scratch on the needle cover, the catheter tubing and needle were not bent, and the needle hub itself was bent.Bending as seen in this unit is known to prevent retraction of the needle.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
 
Event Description
It was reported while using bd insyte¿ autoguard¿ winged shielded iv catheter 22ga 1.00in the needle failed to retract.There was no report of patient impact.The following information was provided by the initial reporter: the customer's verbatim report is as follows: (2) the hcp pressed the button, but the needle was not retracted (registered as needle retraction failure).
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14164346
MDR Text Key289901107
Report Number1710034-2022-00204
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2022
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 Date05/31/2024
Device Catalogue Number381923
Device Lot Number1144359
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2022
Initial Date FDA Received04/20/2022
Supplement Dates Manufacturer Received05/05/2022
Supplement Dates FDA Received05/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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