• 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¿ 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¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381844
Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation results: one sample unit was received for evaluation by our quality engineer team. Upon examination, the unit was observed to be partially open at both ends of the blister packaging. The packages were analyzed under uv light as the adhesive used is uv fluorescent. The analysis revealed an adequate amount of top web adhesive. Although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect. Proper personnel have been notified of this issue for further review. Lot analysis: device/batch history record review: yes: reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr). This investigation is mdr. Findings: a total of (b)(4) units were manufactured on afa line 8 from 8 feb 2015 through 13 feb 2015 and packaged on packaging line 11 from 11 feb 2015 through 14 feb 2015. In process inspections (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications. Qn / sap database review: yes. Reason: dhr was reviewed findings: see findings on dhr review. The peura (end user risk analysis): yes, review of the peura is required for all mdr reportable investigations. Findings: (b)(4) was analyzed to determine the risk to customer. The analysis showed that current risk is acceptable. Occurrence and severity rankings have not changed. Visual analysis observations and testing: received one unused 18ga insyte autoguard unit from lot number 5037912. Visual/microscopic examination: the unit received was partially open at both ends. The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer. This characteristic was met. In addition the paper top web of the returned unit was analyzed under uv light. The glue used to seal the top and bottom webs is uv fluorescent. The analysis revealed an adequate of top web adhesive. The key variables that affect seal strength are: seal transfer/width and top web glue. Both of these variables were looked at during the investigation. Investigation samples(s) meet manufacturing specifications: yes; the returned unit provided for evaluation for this incident met the manufacturing specification requirements. Was the device used for treatment or diagnosis? treatment. Conclusions: the defect stated in the event description was confirmed with the returned unit. Even though the reported defect was confirmed, all the processes characteristics that directly influence the seal strength were observed to be within specification. No anomalies were found. Did the evaluation confirm the customer's experience with the bd product? yes; the customer experience was confirmed based on the evaluation that was performed on the returned units. Were we able to reproduce the customer's experience with the bd product? no; it was not necessary to achieve reproduction of the customer¿s experience, as the defect was confirmed. Relationship of device to the reported incident: indeterminate comment: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect. Capa (b)(4) has been opened to investigate the package open seal defects and implement corrective actions. Other actions taken (if applicable): product quality is evaluated during the manufacturing and packaging process with prescribed attributes inspections. These inspections are performed by operators to ensure any gross process changes are identified. If defects are observed, disposition of the product, root cause and corrective action(s) are applied according to the quality control plan.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the seal on the bd insyte autoguard shielded iv catheter was open prior to use. No serious injury or medical intervention noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSYTE¿ AUTOGUARD¿ 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 Key7147980
MDR Text Key282335967
Report Number1710034-2017-00525
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2018
Device Catalogue Number381844
Device Lot Number5037912
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/27/2017 Patient Sequence Number: 1
-
-