MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381533
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced catheter tip damage/deformation/defective.The following information was provided by the initial reporter: material no.: 381533, batch no.: unknown.Tip of a insyte autoguard is malfunctioning.There have been two recent devices given to me that had issues in our pre-op department.I do not have the lot number for this particular incident.I since have had another device given to me and it did include the package.The lot number for this one is 0342575.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced catheter tip damage/deformation/defective.The following information was provided by the initial reporter: material no.: 381533 batch no.: unknown.Tip of a insyte autoguard is malfunctioning.There have been two recent devices given to me that had issues in our pre-op department.I do not have the lot number for this particular incident.I since have had another device given to me and it did include the package.The lot number for this one is 0342575.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes d10: returned to manufacturer on: 2021-05-13.H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one catheter adapter assembly.Upon inspection of the received unit, it was found that the tip of the catheter was bent at a slight angle and the needle had pierced through the catheter wall near the tip.The reported defect was confirmed.This type of defect can occur during the manufacturing process or in the clinical setting.There is an automated vision system in place that inspects the products during manufacturing, as well as a sampling plan to mitigate the occurrence of this defect.Since the package had been opened, it is also possible the defect occurred during tip adhesion break.Based on the information available, bd could not determine with certainty if the defect occurred during manufacturing or in the user environment.A device history record review could not be performed as the lot number is unknown.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.H3 other text : see h10.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11895907
• Report Number: 1710034-2021-00448
• Device Sequence Number: 3685891
• Product Code: FOZ
• UDI-Device Identifier: 00382903815333
• UDI-Public: 00382903815333
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 381533
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1