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

Catalog Number 38182314

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with needle retraction failure.There was no report of injury or medical intervention.

Event Description

It was reported with the use of the bd insyte autoguard shielded iv catheter there was an issue with needle retraction failure.There was no report of injury or medical intervention.

Manufacturer Narrative

Our quality engineer was able to verify the reported complaint per the picture and sample received, the needle is partially retracted.Although the compliant could be verified, the root cause could not be determined even after reviewing the device history record and quality notifications.

Manufacturer Narrative

Our quality engineer was able to verify the reported complaint per the picture and sample received, the needle is partially retracted.Although the compliant could be verified, the root cause could not be determined even after reviewing the device history record and quality notifications.

Event Description

It was reported with the use of the bd insyte autoguard shielded iv catheter there was an issue with needle retraction failure.There was no report of injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 7880843
• MDR Text Key: 120531444
• Report Number: 9610048-2018-00134
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 38182314
• Device Lot Number: 8061973
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other