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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¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  malfunction  
Event Description
It was reported that 10 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a damaged unit package that compromised sterility.The following information was provided by the initial reporter: " during inspection at the customer's side, 10 packages were found to be damaged/torn.".
 
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: 11/29/2021.H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received 50 sealed 22g x 1.00in.Insyte autoguard bc pro units from lot number 1111856.In addition, five photographs were provided for investigation.A gross visual inspection of the returned units found that nine of the units had tears on the top web near the proximal end of the barrel.The tears had stains on the top and bottom side of the top web.The shape of the tear was in either a semi-circle shape or v-shape.The tears on some of the units were rolled back and up as if it the material was peeled back.No damage was noted to the returned dispenser box or the bottom web of the torn units.The reported issue was confirmed.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.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 that 10 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a damaged unit package that compromised sterility.The following information was provided by the initial reporter: " during inspection at the customer's side, 10 packages were found to be damaged/torn.".
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
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 Key12969006
MDR Text Key285806433
Report Number1710034-2021-01039
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 12/21/2021
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 Date03/31/2024
Device Catalogue Number381023
Device Lot Number1111856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2021
Initial Date FDA Received12/09/2021
Supplement Dates Manufacturer Received12/21/2021
Supplement Dates FDA Received01/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
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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