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

Model Number 381823

Device Problem Packaging Problem (3007)

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

Event Date 11/25/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 30 bd insyte¿ autoguard¿ shielded iv catheter unit package was damaged.The following information was provided by the initial reporter: on (b)(6) 2022, during packaging operations of prohance 1 pfs x 17 ml manu trs fr/m va22010b, pharmaceutical production operators found 30 bd insyte autoguard 22 g with the edges of the package torn.Considering that the edge seems shredded, the sterility could be compromised.

Event Description

It was reported that 30 bd insyte¿ autoguard¿ shielded iv catheter unit package was damaged.The following information was provided by the initial reporter: on (b)(6) 2022, during packaging operations of prohance 1 pfs x 17 ml manu trs fr/m va22010b, pharmaceutical production operators found 30 bd insyte autoguard 22 g with the edges of the package torn.Considering that the edge seems shredded, the sterility could be compromised.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed the top web of three different 22g insyte autoguard units.The product information is not visible in any of the pictures.The top edge of the top web can be seen damaged in each of the units.The perforation line appears to be present on all units.Although the reported issue was confirmed, the photographs provided insufficient evidence to determine a root cause.H3 other text : see h10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 16018082
• MDR Text Key: 308261601
• Report Number: 1710034-2022-00833
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K952861
• 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: 02/21/2023

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 Model Number: 381823
• Device Catalogue Number: 381823
• Device Lot Number: 2165156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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