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

Catalog Number 381823

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/25/2023

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 rust noted in the safety barrel.The following information was provided by the initial reporter, translated from spanish to english: medical device is dispensed and when they uncover the packaging they notice that the device has a dark colouring on the transparent part with the appearance of rust.They went to the pharmacy, checked the device and it was clearly in accordance with the information provided by the nursing staff.

Manufacturer Narrative

Investigation results: the complaint of discoloration on the molded grip was confirmed and the cause appeared to be manufacturing related.Four photographs were provided for investigation, which showed a 22g insyte autoguard device.The discoloration of the grip indicates that non-foreign material, such as burnt resin, was likely embedded within the component during the molding process.The appropriate manufacturing personnel were notified of this complaint.Investigation conclusion(s): the discoloration of the grip indicates that non-foreign material, such as burnt resin.Probable root cause conclusion(s): the defect originated during the molding process of the grip.This is not a mdr reportable event.Cancel mdr.

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: 18503027
• MDR Text Key: 333144949
• Report Number: 1710034-2023-01526
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: (01)00382903818235
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: 381823
• Device Lot Number: 2335742
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1