• Decrease font size
  • Return font size to normal
  • Increase font size
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 INTERVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 382533
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The initial reporter also notified the fda on 04/2018 via medwatch (b)(4). A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that when a bd insyte¿ autoguard¿ bc shielded iv catheter was placed the blood control did not work, causing a leak. There was no report of exposure, serious injury or medical interventions.
 
Manufacturer Narrative
Investigation summary: device/batch history record review findings: dhr review was performed on the lot number 7276574. The lot number was built and packaged on afa line 11 from october 10, 2017 thru october 14, 2017. Per review of the dhr¿s it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans. Set-up and in-process samples (included but not limited) no septum challenge, no actuator challenge, unseated septum, actuator pushed thru septum, actuator/septum present, needle pierce thru septum, blood escape time test, and catheter/adapter water/air leak inspection were performed on various stages throughout the process, all the inspections passed per specifications. The peura (end user risk analysis) was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. Observations and testing could not be performed because units were not received for investigation of this incident. Conclusions: the defect leakage beyond the septum; as stated as the reported code could not be identified or confirmed, and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing. Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir. A formal corrective action will not be initiated at this time. Customer complaint trends are evaluated monthly. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Event Description
It was reported that when a bd insyte¿ autoguard¿ bc shielded iv catheter was placed the blood control did not work, causing a leak. There was no report of exposure, serious injury or medical interventions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7562107
MDR Text Key109951256
Report Number1710034-2018-00244
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825333
UDI-Public30382903825333
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Catalogue Number382533
Device Lot Number7276574
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/01/2018 Patient Sequence Number: 1
-
-