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

Catalog Number 381812

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard needle partially retracted.The following information was provided by the initial reporter: after nurse placed on the patient, she activated the white button and removed the hard needle.She did not pay attention to the fact that the needle was not fully recovered, resulting in an accidental needle stick.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

Investigation results: the complaint that the needle would not fully retract could not be replicated during the sample analysis; however, the reported issue may have occurred due to the circumstantial evidence of the returned sample.One needle and shield from an insyte autoguard device were provided for investigation.The needle was received fully retracted.The barrel was cracked open.The damage to the barrel was likely associated with the reported issue and may have prevented full retraction of the needle hub within the shield during clinical use; however, a functional test revealed that the needle would fully retract when the safety mechanism was activated.As the available data supports the complainant¿s description of the reported event, the complaint was confirmed; however, due to the evidence of use and obvious damage, it could not be determined when or how the barrel was damaged.The dhr for lot 3093652 was reviewed.No related quality issues or process deviations were found.Complaints received for this product and condition will continue to be tracked and trended.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOGUARD
• 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: 19087704
• MDR Text Key: 340685703
• Report Number: 1710034-2024-00323
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: (01)00382903818129
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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 Catalogue Number: 381812
• Device Lot Number: 3093652
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other