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

Model Number 381423

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/08/2022

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 needle failed to retract on the bd insyte¿ autoguard¿ shielded iv catheter, leading to a needlestick injury.The following information was provided by the initial reporter: nurse was stuck with a needle of the 22 g that did not retract (insyte autoguard) post insertion to the patient.

Event Description

It was reported that needle failed to retract on the bd insyte¿ autoguard¿ shielded iv catheter, leading to a needlestick injury.The following information was provided by the initial reporter: nurse was stuck with a needle of the 22 g that did not retract (insyte autoguard) post insertion to the patient.

Manufacturer Narrative

Investigation: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a view of a view of the top web (label) of a unit package from product 22ga bd insyte autoguard iv catheter, reference number (b)(4), lot number 0032352.The photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.A device history record review showed no non-conformance's associated with this issue during the production of this batch.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13696105
• MDR Text Key: 286969711
• Report Number: 1710034-2022-00111
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814237
• UDI-Public: 00382903814237
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 0032352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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