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

Catalog Number 382944

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/22/2020

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.

Event Description

It was reported that the needle would not retract after use and nurse received needle stick injury with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter: the safety system didn't engage properly, the nurse pricked herself.The defect led to a puncture in the palm of the user's hand.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2020-05-14.Investigation summary bd received an 18 gauge insyte autoguard blood control unit from lot 9305412 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned device and noted that the device appeared to have been used and was returned in the retracted position.The returned unit was inspected for any visible damage to the components but no defects were identified.Next, the device was reset to the out position and the safety button was depressed.Retraction was successful with no signs of catching or snagging observed.The needle was reset multiple times with no issues observed.It was then dissected and the hub was inspected for any damage.No damage was found and there were no issues with the spring mechanism.Based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found and no visible damage was observed a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.

Event Description

It was reported that the needle would not retract after use and nurse received needle stick injury with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter: the safety system didn't engage properly, the nurse pricked herself.The defect led to a puncture in the palm of the user's hand.

• Brand Name: 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
• MDR Report Key: 10049173
• MDR Text Key: 191156666
• Report Number: 1710034-2020-00301
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 382944
• Device Lot Number: 9305412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention