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

Model Number 381433

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: the defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced a needle that would not retract, a needle that was partially retracted, and blood exposure.The product defects resulted in a dirty needle stick injury to the device operator.No medical intervention was administered.The following information was provided by the initial reporter: over the past few days, there have been two instances of needle sticks to rn¿s using iv start needles and the reported cause of both was: safety mechanism not engaging.Emergency department: needle stick using an iv start needle.The safety mechanism did not fully activate.The iv needle was 20 gauge x 1 inch, 1.1 x 25mm bd instyle autoguard.Same day surgery: needle stick to rn after iv start on patient, stuck finger attempting to activate safety mechanism ¿ the safety did not activate correctly.The iv start needle was also the 20 gauge x 1 inch, 1.1 x 25mm bd instyle autoguard, lot number 1076405.Have any of the nurses requested medical attention? not at this time, rn wrapped finger at time of incident to prevent further bleeding or infection.Was the needle stick before or after the use of the iv¿s? after.Rn was stuck attempting to withdraw needle from patient after safety mechanism would not engage.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12241948
• MDR Text Key: 265804145
• Report Number: 1710034-2021-00627
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814337
• UDI-Public: 30382903814337
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 381433
• Device Catalogue Number: 381433
• Device Lot Number: 1076405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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