MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 G X 0.75 IN.; SAFETY DEVICE INTRAVENOUS CATHETER

Catalog Number 381412

Device Problem Positioning Failure (1158)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the safety feature of the suspect device failed to deploy after "multiple attempts" to engage it.This failure resulted in a needlestick injury to the clinician; lab work was drawn per facility protocol.

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 4148994.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate of confirm the customer¿s indicated failure mode.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 G X 0.75 IN.
• Type of Device: SAFETY DEVICE INTRAVENOUS 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: 5826733
• MDR Text Key: 50576077
• Report Number: 1710034-2016-00035
• Device Sequence Number: 1
• Product Code: FOZ
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

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
• Device Operator: Nurse
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 381412
• Device Lot Number: 4148994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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