MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC BLU 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 382523

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Address information was not provided, therefore, xx was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 5 bd insyte autog bc blu 22ga x 1.0in needles wouldn't retract.The following information was provided by the initial reporter: it was reported by customer that the needle will not retract when the button is pushed.They have a video showing this.Only way in which they were able to do this was by moving the catheter.It seems as though a piece of the button is getting stuck on the catheter luer lock.Additional information received: "their pt rn noticed the defect while inserting ivs, their pt rn also said it has occurred roughly 4-5 times while inserting ivs.4.The sample is no longer available.They saw how many were defective and then those needles were disposed of in their sharps container.".

Manufacturer Narrative

Investigation results: a device history record review was completed by our quality engineer team for provided material number 382523 and lot number 3249704.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOG BC BLU 22GA X 1.0IN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18822800
• MDR Text Key: 337626819
• Report Number: 1710034-2024-00149
• Device Sequence Number: 1
• Product Code: FOZ
• 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: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382523
• Device Lot Number: 3249704
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1