MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN.; INTRAVASCULAR CATHETER

Catalog Number 381834

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

Investigation: observations and testing could not be performed because units were not received for investigation.Device history record review was performed on the following lot number: 7080821 ¿ the lot number was built on afa line 1, from march 25, 2017 thru march 30, 2017.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications (b)(4), 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.The defect of needle stick injury, as stated in the subject of the pir could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing.Without a sample, an absolute root cause for this incident cannot be determined.(b)(4).

Event Description

It was reported that the safety mechanism on a bd insyte¿ autoguard¿ shielded iv catheter 20 g x 1.16 in.Did not function properly, causing a dirty needle stick on the finger of a healthcare worker.This incident was reported through health and safety at the workplace and medical exams and emergency assessment was performed but there were no specific labs or tests mentioned.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6942559
• MDR Text Key: 89223332
• Report Number: 1710034-2017-00261
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 381834
• Device Lot Number: 7080821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention