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

Catalog Number 382523

Device Problem Split (2537)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 during use a bd insyte¿ autoguard¿ bc shielded iv catheter was found splitting.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the defect reported.Device/batch history record review was conducted with the following results disclosed: lot 7275538 was built and packaged on afa line11 on 07oct2017 through 10oct2017 for the quantity of (b)(4) ea.Review disclosed no indication of the alleged defect, as there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product relevant to the defect stated in the pir.All required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.Set-up and in-process samples (including but not limited to) for damaged component and pen and drag testing were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.No significant discoveries were disclosed.Sap (qn) database review findings: subject code was an s2 severity ranking.As a result of the review there were no reject activity findings relevant to the defect noted in the pir associated with the lot number provided for this incident.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.Observations and testing could not be performed because units were not received for investigation of this incident.Conclusions: confirmation of the defect stated in the pir could not be identified or confirmed and cause could not be determined, as the units described in the product incident report were not provided for evaluation and testing.Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.This incident is indeterminate.A root cause could not be established.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.

• 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: 7334563
• MDR Text Key: 102337997
• Report Number: 1710034-2018-00090
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 382523
• Device Lot Number: 7275538
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other