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

Model Number 381411

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd insyte-n¿ autoguard¿ shielded iv catheter tip was shredded during use.The following information was provided by the initial reporter: "catheter shredded; multiple nurses have complained about the catheter tip being "shredded.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 15-feb-2023.H6: investigation summary: our quality engineer inspected the representative samples submitted for evaluation.Bd received 19 sealed 24gx0.56in insyte autoguard devices from lot number 2146291.No physical damage was observed with any of the units.A pen and drag test was performed to measure the needle and catheter penetration force.All units were within specification.The units were further inspected under the microscope and no damage was found on the catheter nor the needle.The units were then tested for retraction failure.Tip adhesion was performed, and the safety button was activated on all the units.Upon activation, the needle retracted safely in the safety shield without any resistance.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure of retraction failures and corrective actions have been initiated to investigate this type of incident and identity the root cause.

Event Description

It was reported that the bd insyte-n¿ autoguard¿ shielded iv catheter tip was shredded during use.The following information was provided by the initial reporter: "catheter shredded.Multiple nurses have complained about the catheter tip being "shredded.".

• Brand Name: BD INSYTE-N¿ 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: 16376055
• MDR Text Key: 309568827
• Report Number: 1710034-2023-00105
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814114
• UDI-Public: 00382903814114
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381411
• Device Catalogue Number: 381411
• Device Lot Number: 2146291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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