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

Catalog Number 381434

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard shelf pack is incorrectly labeled.The following information was provided by the initial reporter: we received some product from medline in packaging that is different from what we usually see.Product inside blue box is the 22 ga x 1 in¿label/reference on box reflects 20g pink autoguard.Mis- labeled lot #4010709.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.Our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs.The first image displayed three dispenser boxes from what appeared to be lot #4010709.Each dispenser box was labeled with reference number 381434.The product description on the label (20 ga x 1.16 in) was positioned on a blue background.20 ga devices coincide with the color pink and the background color on the label should have been pink.The contents of the dispenser box were not visible in the photo.The second image displayed one dispenser box with the same material # with the correct pink background.The lot # on the label was 3277682.It appeared that this image was used as a comparison and to demonstrate the correct label.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an incorrect machine set-up in the packaging process.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• 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: 19085261
• MDR Text Key: 340576333
• Report Number: 1710034-2024-00315
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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: Other
• Device Catalogue Number: 381434
• Device Lot Number: 4010709
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1