MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ CATHETER; INTRAVASCULAR CATHETER

Model Number 381812

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte¿ autoguard¿ catheter the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the nursing technician encountered resistance when pulling the jelco 24 to remove the needle.When he was able to identify that the silicone catheter was broken and came out with the needle.

Manufacturer Narrative

H6: investigation summary a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1111217, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the tip of the needle had pierced through the catheter tubing.The device appeared to have been used as media was present in the catheter and throughout the flashback chamber.Therefore, based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for inspection a definitive root cause could not be determined.

Event Description

It was reported while using bd insyte¿ autoguard¿ catheter the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the nursing technician encountered resistance when pulling the jelco 24 to remove the needle.When he was able to identify that the silicone catheter was broken and came out with the needle,.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16272464
• MDR Text Key: 308706331
• Report Number: 9610048-2023-00002
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 381812
• Device Catalogue Number: 38181214
• Device Lot Number: 1111217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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