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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 INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382533
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 a bd insyte¿ autoguard¿ bc shielded iv catheter contained foreign matter covered with small shredded pieces of plastic on the catheter. Found before use. No report of serious injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: the device history report for lot number 8061541 was reviewed, no related abnormalities were found. Material number 382533 for lot8 061541 was manufactured on 12/08/2017 - 12/11/2017. This is the first instance of this failure mode with this lot number. According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections. Additionally a sample was submitted for the purpose of aiding our quality engineer in their investigation. Visual observation of the device determined that the catheter tubing had clear plastic fibers on the exterior of the device. Investigators determined that the failure mode was caused by the manufacturing process. Investigation conclusion: foreign matter can be loosely attached to the catheter tubing due to the silicone lube during the manufacturing process.
 
Event Description
It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter contained foreign matter covered with small shredded pieces of plastic on the catheter. Found before use. No report of serious injury or medical intervention.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7653052
MDR Text Key113004313
Report Number1710034-2018-00373
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Catalogue Number382533
Device Lot Number8061541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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