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

Catalog Number 381012

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/21/2018

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 there was black foreign matter on the bd insyte¿ autoguard¿ bc shielded iv catheter.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Received a 24ga iag bc unit with no packaging.All components were intact.A complaint history check was performed and this is the 4th related complaint reported with the defect/condition of foreign matter with lot # 8078550 regarding item #381012.The lot number was built on afa line 10 from (b)(6) 2018 thru (b)(6) 2018.Packaged on packaging line 9 from (b)(6) 2018 thru (b)(6) 2018.All challenges, set up and in-process samples were performed according to the quality control plan and all passed per specifications.No quality notifications were initiated during production.The black specks embedded in the needle cover observed during the investigation was burnt particulate resin that was a result of the molding process would not affect fit, form or function of the product.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.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.

Event Description

It was reported that there was black foreign matter on the bd insyte autoguard bc shielded iv catheter.There was no report of exposure, injury, or medical intervention.

• 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: 7938592
• MDR Text Key: 123208868
• Report Number: 1710034-2018-00679
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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: 381012
• Device Lot Number: 8078550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other