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

Catalog Number 381434

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: 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 could not be performed as a lot number was not available.Confirmation of the defect stated in 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.Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects 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.

Event Description

It was reported that the safety mechanism on a bd insyte¿ autoguard¿ shielded iv catheter failed to retract, leaving the needle exposed.There was no report of injury or medical interventions.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• 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: 7404095
• MDR Text Key: 104703043
• Report Number: 1710034-2018-00143
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814344
• UDI-Public: 30382903814344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 381434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other