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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 WITH BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381012
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: our quality engineer inspected the samples and photographs submitted for evaluation. Bd received five units and two photos. Upon inspection of the photos and the received units, it was identified that black tape was present between the top and bottom web in two of the five packages. Those two packages were also found to have incomplete seals due to the black tape. The defect of foreign matter was confirmed. The foreign matter was identified as black splice tape which is used during the packaging process. There is a 100% vision system for detecting splice tape. Additionally, operators perform periodic inspections per the sampling plans. It is the operator¿s job to follow the splice through the machine to insure it travels through the machine as intended and to make sure the row with the splice tape is discarded by the vision system at the end of the machine. Therefore, this defect can be linked to packaging/manufacturing personnel error. A device history record review showed no non-conformance's associated with this issue during the production of this batch. The appropriate personnel have been notified. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 2 bd insyte¿ autoguard¿ bc shielded iv catheters with blood control technology had packaging units with incomplete seals that compromised their sterility. The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about dirty packages of iagbc. According to the customer's report, the inside of the label on the package was severely stained with black dirt. " via bd investigation: "upon inspection of the photos and the received units, it was identified that black tape was present between the top and bottom web in two of the five packages. Those two packages were also found to have incomplete seals due to the black tape. ".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key12618959
MDR Text Key276165383
Report Number1710034-2021-00878
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381012
Device Lot Number0216661
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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