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

Catalog Number 381434

Device Problems Fail-Safe Design Failure (1222); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: a sample has been received for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the employee started the iv with the suspect device.When the employee pushed the button to retract the needle, it retracted and then came out the side, resulting in a needle stick injury to the employee's hand.

Manufacturer Narrative

The manufacturing site received one used (b)(4) unit with an opened package from the lot number 6061733.The unit consisted of the needle safety barrel assembly.A visual/microscopic examination was performed and it was observed that the needle was fully retracted into the safety barrel and the white button was depressed.The needle was pushed and repositioned to the out position; observed the needle was slightly bent approximately 5/8 of an inch above the needle hub.No needle cover was returned for evaluation.A function test (needle retraction) was performed.The needle was pushed and repositioned to the out position.The button was depressed and the needle retracted fully within the safety barrel.The retraction was successful, meeting no resistance.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6061733.There were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.The customer's reported defect was not confirmed as the returned unit did not display any adverse characteristics that would contribute to the defects the customer experienced.There was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident.An absolute root cause for this incident cannot be determined.

• Brand Name: 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: SHIELDED IV 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: 6228267
• MDR Text Key: 64025634
• Report Number: 1710034-2017-00001
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

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: Other
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 381434
• Device Lot Number: 6061733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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