MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD INSYTE AUTOGARD CATHETER; INTRAVASCULAR CATHETER

Catalog Number 38831214

Device Problem Material Perforation (2205)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Patient¿s birthday was not provided, (b)(6) was used based on age of patient.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 autogard catheter the needle pierced the catheter.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: catheter number 22 that they dispatch from the pharmacy , at the time of testing the catheter, it is perforated in the distal part of the catheter - the branula is changed for another catheter.

Event Description

It was reported while using bd insyte autogard catheter the needle pierced the catheter.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: catheter number 22 that they dispatch from the pharmacy , at the time of testing the catheter, it is perforated in the distal part of the catheter - the branula is changed for another catheter.

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, 2178664, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed two insyte devices.Both devices appeared to have the needle piercing through the catheter tubing and one device looked unused while the other was used.Therefore, based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for evaluation a definitive root cause could not be determined.

• Brand Name: BD INSYTE AUTOGARD CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16250763
• MDR Text Key: 308937708
• Report Number: 3003916417-2023-00011
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38831214
• Device Lot Number: 2178664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Patient Age: 67 YR