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

Catalog Number 382923

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/19/2018

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 during use of the bd insyte¿ autoguard¿ bc winged when the needle was activated, "the needle did not remain completely in the tube." there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: lot analysis.Findings: as this complaint was a mdr; -dhr review was performed on the lot number 7198563.The lot number was built on afa line 10, from july 20, 2017 thru july 28, 2017.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Qn / sap database review: yes.Reason: a review of the qn/sap database is required for a s2 ¿ o1 level a investigation per cpr ¿ 071.The peura (end user risk analysis): yes.Reason: the peura is required for all mdr reportable investigations.Findings: (b)(4) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Visual analysis.Observations and testing: received one used iag/bc 22ga unit with an opened package from the lot number 7198563.The unit consisted of the needle safety barrel assembly.Visual/microscopic examination: observed the needle was fully retracted into the safety barrel.Observed damage on the grip; inward causing the partial retraction.The damage was in the area at the bottom of the grip where it connects to the barrel.Functional test (needle retraction) was performed: the needle was pushed and repositioned to the out position.The button was depressed and retraction was unsuccessful.Investigation samples(s) meet manufacturing specifications: no; the returned used unit provided for evaluation displayed a damaged grip; which inhibited the needle from retracting investigation conclusion: the defect needle retraction failure; as stated as the reported code was confirmed with the returned unit and the photos submitted for review.The returned unit displayed damage to the grip component.This damage inhibited a full retraction of the needle into the barrel upon activation.Root cause: relationship of device to the reported incident: manufacturing the plug probe and the load barrel stations in zone 5 have the ability to become misaligned and produce the type of damage observed in the returned sample.When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC WINGED
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7247981
• MDR Text Key: 99327033
• Report Number: 1710034-2018-00028
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 382923
• Device Lot Number: 7198563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other