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

Catalog Number 382523

Device Problems Physical Resistance (2578); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/04/2018

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 as the healthcare worker was using a bd insyte¿ autoguard¿ bc shielded iv catheter to cannulate the patient, she put her hand above the insertion site to occlude the vein.When she tried to advance the needle slightly she felt resistance so she pulled the needle back without pressing the button.She stuck her hand which was above with the un-shielded needle.She washed her hands thoroughly and then received post exposure lab work.

Manufacturer Narrative

Investigation summary: lot analysis review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the setup and in-process sampling plans.Setup and in process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.Setup and in process samples for needle penetration difficult by cannula tip quality/ and needle tip penetration/drag test were performed on various stages throughout the process, all the inspections passed per specifications.Visual analysis: observations and testing: received one unused iag/bc 22ga unit in sealed package from the lot number 7317810.Penetration and drag test was performed: during the penetration and drag test the catheter did not accordion, bend, kink, split or wrinkle during insertion.Specification is 32 grams max for needle tip, 35 grams max for catheter tip and 10 grams average for catheter drag.The units were acceptable per specification.Visual/microscopic examination: the bevel area had the proper bevel cut and the secondary bevel was present.The needle was not bent, pinched or gripper damage to the needles.There was no mechanical/physical damage to the spring, needle hub, grip, or evidence of glue on the button or hub.The needle was not bent, pinched or damaged.Lie distance: within the acceptable range of.001 - 0.023 inches.Cannula tip quality: rated at a, acceptable.No bends, cuts, holes, kinks, splits, kinks, wrinkles or the characteristic v shape of a spear thru was observed in the tubing of the catheter.Catheter tip grading: graded a 3, acceptable.Tip adhesion: holding the catheter hub, manually rotated the clear barrels 360 degrees, observed no candy caning and there was no stickiness felt.Functional test (needle retraction): the button was depressed, and the needle retraction was successful, not fast nor slow; meeting no resistance.Investigation conclusion: the defects of needle penetration difficult/painful and needle stick injury, as stated as the reported codes, were not confirmed.The returned units did not display any adverse characteristics that would contribute to the defects the customer experienced.The defects described in the incident report could not be confirmed or replicated with the returned unit.The actual unit described in the incident report was not returned for evaluation.Root cause: relationship of device to the reported incident: indeterminate.There was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident.

• 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: 7451254
• MDR Text Key: 106188810
• Report Number: 1710034-2018-00168
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 382523
• Device Lot Number: 7317810
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention