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

Catalog Number 381833

Device Problems Retraction Problem (1536); Component Missing (2306)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

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 bd insyte autoguard had a needle retraction problem with report of a missing spring.The following information was provided by the initial reporter, translated from french to english: a 3ap nurse was injured on friday, (b)(6) 2023, while activating the safety of a peripheral venous catheter.She held the catheter between her thumb and forefinger.When she activated the security, by pressing the white button with her thumb, she felt a sting ? a pinch ? at the index level.When she looked at the device and compared it with another device she had just opened, she noticed that a piece of the plastic part protecting the spring was missing.The nurse did not keep the offending catheter.It was a bd insyte autoguard 20 ga ref 381833.Currently, devices from the lot 3055420 expiry date 2026-02-28 are used in the service.Consequences : no wound a priori but potential risk of exposure to the patient's blood location of the device : not preserved, not available for expertise.

Manufacturer Narrative

(b)(4), follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 381833 and lot number 3055420.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.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see manufacturer narrative.

Event Description

It was reported that bd insyte autoguard had a needle retraction problem with report of a missing spring.The following information was provided by the initial reporter, translated from french to english: a 3ap nurse was injured on friday, (b)(6), 2023, while activating the safety of a peripheral venous catheter.She held the catheter between her thumb and forefinger.When she activated the security, by pressing the white button with her thumb, she felt a sting ? a pinch ? at the index level.When she looked at the device and compared it with another device she had just opened, she noticed that a piece of the plastic part protecting the spring was missing.The nurse did not keep the offending catheter.It was a bd insyte autoguard 20 ga ref 381833.Currently, devices from the lot 3055420 expiry date 2026-02-28 are used in the service.Consequences : no wound a priori but potential risk of exposure to the patient's blood location of the device : not preserved, not available for expertise.

• 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: 18313295
• MDR Text Key: 330938457
• Report Number: 1710034-2023-01440
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818334
• UDI-Public: (01)00382903818334
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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: Health Professional
• Device Catalogue Number: 381833
• Device Lot Number: 3055420
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1