MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X1" BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

Catalog Number 382523

Device Problems Retraction Problem (1536); Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

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 following patient use, the clinician retracted the needle on the suspect device.When the clinician went to place the needle in the sharps collector the clinician turned back to the patient and missed the sharps collector.The needle fell, hitting the patient in the palm of his/her hand and the needle then bounced out of the chamber and stuck the clinician.Both the clinician and source patient had lab work.No prophylactic medication was prescribed at this time.It was noted that with an unused needle, the clinicians at the user facility replicated the dropping of the retracted needle and the needle came out of the chamber again.

Manufacturer Narrative

Device evaluation: result - a review of the device history record was performed on the reported lot number 6099527.This lot was built between 4/12/2016 and 4/14/2016.All required challenges samples and testing was performed per specifications and there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.The manufacturing site received one used device with a paper top web from the lot number 6099527.The unit consisted of the needle safety barrel assembly.Visual examination revealed 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 and there was no mechanical/physical damage to the spring or needle hub or grip.There was no evidence of adhesive on the button, grip or hub.A functional test (needle retraction) was performed.After the needle was pushed and repositioned to the out position, the button was depressed, at which point the needle retracted fully within the safety barrel.The retraction was successful, meeting no resistance.After the needle was retracted, it was dropped to the floor to create the customer¿s experience.The needle remained retracted inside of the grip.Conclusion - bd could not duplicate or confirm the reported defect.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced.Bd quality engineering does not know how to replicate this experience.Bd has never seen this happen with the device and cannot determine how this occurred.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 cannot be determined.

• Brand Name: 22 G X1" BD INSYTE¿ AUTOGUARD¿ BC 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: 5946282
• MDR Text Key: 54578132
• Report Number: 1710034-2016-00040
• 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: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 382523
• Device Lot Number: 6099527
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention