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

Catalog Number 381023

Device Problem Missing Information (4053)

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

Event Date 09/26/2022

Event Type  malfunction  

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.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced missing label information.The following information was provided by the initial reporter: five packages had no product information printed on the tyvek sheet.

Manufacturer Narrative

H6: investigation summary: bdj received five empty packages.They had no product information printed on the tyvek sheet.Our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs displaying five units from a 22gx1.00in insyte autoguard.A gross visual inspection found that no device was present inside the sealed packaging.In addition, the top web of the package is missing label information with all five units therefore, the defects of empty package and missing label content are 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 in the packaging and printing process.This type of defect may occur during manufacturing due to a gripper misalignment failing to pick up a part which is intended to be placed in the bottom web blister.During the automated packaging process there are two detection methods in place that may identify an empty package.These two methods, a 100% online vision system and a part counting scale, must be bypassed for an empty package to be sent out.Missing print may occur during the printing process due to dirty print heads, top web break, top web splice, and software issues.A device history record review could not be performed as the lot number is unknown.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced missing label information.The following information was provided by the initial reporter: five packages had no product information printed on the tyvek sheet.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• 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: 15661086
• MDR Text Key: 306879801
• Report Number: 1710034-2022-00617
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• 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