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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¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381534
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
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 bd insyte¿ autoguard¿ shielded iv catheter had a needle that broke off during use. No report of serious injury or medical intervention.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a needle that broke off during use. No report of serious injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: received one used iag 20ga unit and paper top web label from the lot number 8005758. The unit was received in a plastic container broken up. Dhr review was performed on the lot number 8005857. The lot number was built on afa line 6, from january 8, 2018 thru january 12, 2018. Review of the dhr revealed all required challenges samples, set-up and in-process testing was performed per specification in accordance with the quality sampling plans. Setup and in process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications. No significant discoveries were found. 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. Visual/microscopic evaluation: the wedge/catheter tubing was removed from the adapter and on the needle. The needle/hub was removed from the grip. The needle was curved. The spring was loose and stretched out. The grip and the safety barrel were separated at the area of connection. The ends of both pieces had stress marks and were smashed. Conclusion(s): based on the received condition of the returned unit; the defects needle broken, and needle retraction failure could not be confirmed or replicated with the condition of the returned unit. There was extensive damage to the product. Patient residue observed within the unit indicates the needle and catheter were correctly assembled at the time of use. The extent of damage to the tubing and the cannula exhibited with the returned unit would have been observed during the insertion process by the clinician; therefore, the damage happened after use. There was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident. 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.
 
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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 Key7652915
MDR Text Key113004319
Report Number1710034-2018-00374
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 other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/11/2018
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 Date12/31/2020
Device Catalogue Number381534
Device Lot Number8005857
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
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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