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

Catalog Number 381434

Device Problems Defective Component (2292); Defective Device (2588)

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

Event Date 12/04/2023

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.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd insyte autoguard catheter is defective.The following information was provided by the initial reporter: i have had this problem reported to me a couple of times with 20 and 24g insyte autogards.I have attached lot numbers that i have been able to collect and am working on getting actual malfunctioning product but staff are always hesitant to keep anything with blood on it.I have a malfunctioning product and one of our departments ended up pulling all the 20g ivs.(b)(6) 2023.1.Any adverse event or serious injury reported to patient or healthcare professional? no injury but additional iv insertions so unnecessary discomfort.2 was there a delay of, or change in, the course of treatment due to the event? minor delay in pre op stage due to multiple iv attempts.5.How [5.How] was treatment completed for customer? yes.6.Patient status? no complications.8.Please elaborate the issue? the catheter of the iv itself seems to have issues with integrity.I have had several reports of leaking from the catheter and/or the needle getting caught in irregularities of the catheter.10.Date [10.Date] of event? over the past 6 months.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: the complaint of leaking from the catheter and/or the needle getting caught in the catheter could not be confirmed from the 20g insyte autoguard samples that were provided for investigation.One used sample and 232 representative samples in sealed packaging exhibited no damage or defects that would cause the reported issue.A functional test revealed no leaks in the catheter.Although the returned samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.The dhr for lot 3248258 has been reviewed.No related quality issues or process deviations were found.Investigation conclusion(s): the defects of ¿catheter defective/damaged¿ were not confirmed.Probable root cause(s): a root cause cannot be determined without a confirmed defect.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETER
• 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: 18395146
• MDR Text Key: 331763921
• Report Number: 1710034-2023-01480
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: (01)00382903814343
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381434
• Device Lot Number: 3248258
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1