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

Catalog Number	381544
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Needle did not retract fully into the safety shield.No samples available.Device/batch history record review: per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Set-up and in process samples (including but not limited to) for damaged component (grip, button, spring, hub), needle retraction by button activation and adhesive overfilled/drip, periodic cleaning/alignment of the glue grippers were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Visual analysis: observations and testing: although no physical samples were received from evaluation the customer provided 2 photos.Photo#1 reveals a unit where the needle is partially retracted and photo#2 displays traces of blood on the hub and cracks/stress marks was observe at the bottom of the safety barrel.The evaluation of the pictures provided by the customer revealed there was damage (cracks, stress marks) observed on the safety barrel.Conclusions: the damage (cracks, stress marks) observed on the safety barrel prevented the needle/hub from fully retracting.The failures experienced by the customer could not be confirmed with observations and testing performed on the returned unit.It was unable to reproduce the customer experience, the unit was not returned for evaluation.
Event or Problem Description
It was reported after use of the bd insyte¿ autoguard¿ shielded iv catheter the needle failed to fully retract into the safety shield.There was no report of injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7252631
• Report Number: 1710034-2018-00029
• Device Sequence Number: 1741709
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 381544
• Device Lot Number: 7031805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other