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

Catalog Number	381911
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-n autoguard winged plastic on hub prevented connection.The following information was provided by the initial reporter: date of incident (yyyy-mm-dd): (b)(6) 2024 level of harm: no apparent harm - reached patient/person, inconvenient incident details: attempted to start piv on patient.Writer who was poking for iv as able to get good flashback, however unable to screw flush on as there was an extra nodular piece of plastic noted on the catheter.Impact of incident: this resulted in needing to poke babe second time for piv.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs displaying the 24g insyte-n autoguard.The catheter had been inserted into the patient¿s hand and had been dressed down with a transparent dressing.Examination of the threaded catheter adapter revealed that the outer thread contained damage.The distinguishing characteristics of the damage to the threads could not be seen in the returned photographs; therefore, the exact root cause of the damage to the threads could not be determined from the photograph.Damage to the adapter threads can prevent the catheter adapter from mating with auxiliary devices.This type of damage can occur during manufacturing or in the clinical environment.Damage during manufacturing can occur when the adapter encounters manufacturing equipment (e.G.Grippers).Misalignment of the adapter relative to the equipment may cause this type of damage.Alignment is performed as necessary during set up for production and preventative maintenance (pm¿s) is performed to ensure the equipment is running properly.Additionally, sampling is performed by operators to search for damage to the adapter per the quality control plan.In the clinical environment, damage to the adapter threads can occur during connection with auxiliary devices (e.G.Cross threading the connection).
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE-N AUTOGUARD WINGED
• Common Device Name: 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: 19627254
• Report Number: 1710034-2024-00663
• Device Sequence Number: 20985183
• Product Code: FOZ
• UDI-Device Identifier: 00382903819119
• UDI-Public: (01)00382903819119
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 381911
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown