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

Catalog Number	381033
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had an ink like stain on the package.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: although units were not returned; photos were provided for evaluation of this incident investigation.The photos reveal 5 sealed package of 20ga bd insyte autoguard bc iv catheters from lot 7198573.All components are present and intact.Dhr review for lot 7198573 shows a total of 264,010 units were built on afa line 11, from july 25, 2017 through july 27, 2017.All challenge, set-up and in process samples were performed in accordance to the quality control plan and all passed per specifications.No quality notifications were initiated during production.There were not related reject activity findings relevant to the defect associated with the lot number provided for this incident, as no quality notifications were initiated for this lot.A complaint history check was performed and this is the 3rd related complaint reported with the defect/condition of package damaged/defective/other with lot #7198573 regarding item #381033.Investigation conclusion: two spots of pink dried ink were observed on the top web (label) of the package of one of the five units.The dried ink (non-foreign) observed on the top web of one unit was introduced during the packaging process.Root cause description: doctor blade and analog roller had excess ink build up and needed to be cleaned.The ink (non-foreign) observed in this incident is cosmetic and does not affect fit, form of function of the product.Rationale: 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.
Event or Problem Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had an ink like stain on the package.No serious injury or medical intervention was reported.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 8196478
• Report Number: 1710034-2018-00933
• Device Sequence Number: 1699175
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: 382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 381033
• Device Lot Number: 7198573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other