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

Catalog Number 382534

Device Problem Retraction Problem (1536)

Patient Problem Injury (2348)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a nurse pressed the safety activation button of a 20 g x 1.16 in.Bd insyte¿ autoguard¿ bc shielded iv catheter, the needle did not retract, and the nurse scratched her finger with the contaminated needle.The source patient received post exposure lab work and the nurse took "antivirals" for 24 hours until the patient's blood work came back negative.

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 20 G X 1.16 IN. 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
• 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: 6211310
• MDR Text Key: 63475588
• Report Number: 1710034-2016-00075
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110443
• 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,Followup
• Report Date: 01/23/2017

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 Catalogue Number: 382534
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2017
• 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): Required Intervention