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

Model Number 381834

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that while using bd insyte autoguard, the labels were missing on the outer packaging.This event occurred 5 times.The following information was provided by the initial reporter: "the outer packaging is blank.".

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2021-12-29 investigation summary our quality engineer inspected the samples and photographs submitted for evaluation.Bd received five unopened devices with no packaging print.In addition, two photos were received which displayed similarities to that of the returned units.Through the examination, it was identified that the print is missing.The reported issue was confirmed.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error.This type of defect occurs when the ink on the print heads is running low or need to be purged or if there is a bad cable connection to the print head.There is a 100% vision system that checks for the lot number and other print on the package label.The packages that are missing printed information are rejected and separated into a sorting bin.All packages in the bin are then inspected for product attributes.The acceptable packages are placed into a labeled dispenser, ready for placement into the shipper.If an operator fails to recognize the print error, a unit may be sent out with the reported defect.A dhr review could not be reviewed as the lot number is unknown for this complaint.

Event Description

It was reported that while using bd insyte autoguard, the labels were missing on the outer packaging.This event occurred 5 times.The following information was provided by the initial reporter: "the outer packaging is blank.".

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13158686
• MDR Text Key: 285773930
• Report Number: 1710034-2021-01093
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1