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

Catalog Number 381023

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.Investigation summary: our quality engineer inspected the photographs and samples submitted for evaluation.Bd received four photos and five 22gx1.00in insyte autoguard device from lot number 3033953.The evaluation of the photos displays the device placed incorrectly in the packaging.The photos appear to be the images of the returned units.A gross visual inspection of the returned units shows that there is no damage in 4 units and one unit has multiples damages.The distal part of the unit was placed at the proximal side of the packaging.This incorrect placement likely caused the needle to pierce the bottom web resulting in the sterility breach of the unit with the catheter sticking out.In addition, the needle is retracted in the barrel and the catheter adapter is not seated correctly on the grip as well as the needle and catheter are bent, and the needle cover is missing.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an incorrect equipment set up or a machine misalignment.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text: see h.10.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter's packaging was damaged where sterility of the product was compromised.The following was translated from japanese to english: the customer reported that the needle body and the needle storage cylinder were packaged in opposite directions.Before delivery to the hospital, the needle body and the needle storage cylinder were packaged in opposite directions, and the needle was found bent.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18007769
• MDR Text Key: 326580736
• Report Number: 1710034-2023-01226
• 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
• Report Date: 10/20/2023

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 Catalogue Number: 381023
• Device Lot Number: 3033953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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