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

Catalog Number 381423

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

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard had foreign matter on its catheter.The following information was provided by the initial reporter: black material noted on iv catheter upon opening.Material was noticed before intravenous access placed was there a delay of, or change in, the course of treatment due to the event? no did the issue happen during patient use? if yes, was there any injury? yes.No harm during patient care.Could you please provide a further description of the issue? black material found on the catheter after taken out of packaging.

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.

Manufacturer Narrative

Investigation results: the complaint of black material was confirmed; however, the root cause and origin of the material could not be determined due to the sample condition.The black material was received separate from the catheter and attached to adhesive tape.As the catheter and foreign material were received in open packaging, it could not be determined when or how the material was introduced.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

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: 18369539
• MDR Text Key: 331297939
• Report Number: 1710034-2023-01465
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814237
• UDI-Public: (01)00382903814237
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: 381423
• Device Lot Number: 3228135
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1