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

Catalog Number 381023

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that before use of the bd insyte¿ autoguard¿ bc shielded iv catheter, there was a foreign matter like mold in the sealing part.No serious injury or medical intervention was reported.

Manufacturer Narrative

Received 3 iag 22ga packages from lot number 8069929.All components were present.Unit package seal was open.A complaint history check was performed and this is the 4th related complaint reported with the defect/condition of foreign matter with lot # 8069929, part # 381023.Dhr review shows the lot number was built/package on afa line 12 from march 11, 2018 thru march 17, 2018.All required challenge samples and testing was conducted per specifications and in accordance with quality control plan.Review disclosed quality notification 200738789 was initiated, then later was voided.The peura (end user risk analysis was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.The packaging trim was not removed by the removal vacuum.When the package trim is not removed, it goes around the machine coming into contact with chain oil and it may continue around into the product to be sealed.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.Operations personnel were notified of this reported issue and the results of the investigation.

Event Description

It was reported that before use of the bd insyte autoguard bc shielded iv catheter, there was a foreign matter like mold in the sealing part.No serious injury or medical intervention was reported.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7860503
• MDR Text Key: 119818603
• Report Number: 1710034-2018-00620
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 381023
• Device Lot Number: 8069929
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other