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

Catalog Number 382512

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

Results: a sample is not available 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 is not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).

Event Description

It was reported that a nurse obtained a contaminated needle stick injury from a used 24 g x 0.75 in.Bd insyte¿ autoguard¿ bc shielded iv catheter because the safety activation button jammed and the needle only partially retracted.The nurse washed and cleaned the puncture site and the source patient received post exposure lab work.The test results were negative and no further medical interventions were provided to the nurse or source patient.

Manufacturer Narrative

Results: as previously reported, a sample is not available for evaluation.However, on 12/16/2016, the customer provided two photos of the affected device.A photo inspection revealed the needle was partially retracted into the safety barrel leaving the needle tip exposed.Damage was observed on the grip the unit.The damage was facing inward and in the area at the bottom of the grip where it connects to the barrel.Conclusion: our quality engineer has determined that based off of the returned photos, the root cause for this incident is related to the manufacturing process.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 photos.When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint sample.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.Manufacturing was notified of this incident and the findings.

• Brand Name: 24 G X 0.75 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: 6153005
• MDR Text Key: 61697118
• Report Number: 1710034-2016-00059
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 382512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2016
• 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