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

Model Number 381812

Device Problem Defective Component (2292)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported that while using a bd insyte¿ autoguard¿ shielded iv catheter, the catheter was damaged.The following information was provided by the initial reporter, translated from spanish to english: the patient is channeled, during catheter insertion the catheter is opened.

Manufacturer Narrative

Initial reporter address 1: (b)(6).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 while using a bd insyte¿ autoguard¿ shielded iv catheter, the catheter was damaged.The following information was provided by the initial reporter, translated from spanish to english: the patient is channeled, during catheter insertion the catheter is opened.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that while using a bd insyte¿ autoguard¿ shielded iv catheter, the catheter was damaged.The following information was provided by the initial reporter, translated from spanish to english: the patient is channeled, during catheter insertion the catheter is opened.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 01-jan-2023.H6: investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received one 24gx0.75in insyte autoguard unit from lot number 1274991.The gross visual inspection displays a unit where the needle is still in the catheter and bent at the notch.There is no sign of use on the device though the needle cap is missing, and the needle is partially retracted in the needle hub.The catheter adapter appears to have a scratch on its side and the catheter has damage that was made by the needle.The reported issue was confirmed.It could not be determined if the damage occurred during manufacturing, use, or handling.It appeared that the catheter damage either occurred concurrently with the needle damage or the damaged needle was a potential contributing factor of the catheter damage.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 15161227
• MDR Text Key: 302473495
• Report Number: 1710034-2022-00411
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381812
• Device Catalogue Number: 381812
• Device Lot Number: 1274991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• 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