MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC; PERIPHERAL IV CATHETERS

Catalog Number 382533

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.An additional lot number was provided in this complaint for material number 382533.Lot # 4007165 mnf date 11 jan 2024 exp date 31 dec 2026.

Event Description

It was reported that bd insyte autog bc needle is not retracting.The following information was provided by the initial reporter: southcoast has reported that the following bd needle is not retracting.

Event Description

No additional information.

Manufacturer Narrative

A device history record review was completed by our quality engineer team for provided material number 382533 and lot number 4007165 and 4004948.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.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE AUTOG BC
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 19193181
• MDR Text Key: 342000724
• Report Number: 1710034-2024-00364
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: (01)00382903825332
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2024

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: 382533
• Device Lot Number: 4004948
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 07/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1