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

Catalog Number 388312

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle detached from the hub of a bd insyte¿ and remained in the patient.The needle was immediately withdrawn.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: samples/ photos: according to the visual analysis of the photos, of the product containing the sample claimed, it was possible to verify that the needle pulled out of the hub.Dhr review: the final assembly lot: 7179921, used in the claimed final product lot: 7173852 was produced from 06/30/2017 to 07/13/2017 in icam # 02.After analyzing this document, a record of failure in the "challenge of the cannula x hub pull off test" on 07/12/2017 at 10:00 was evidenced that may be related to this complaint.This test verifies that 100% of the assembled parts have the needle bonded into the hub after application and curing of the glue.The final assembly lot: 7150926, used in the claimed final product lot: 7173852 was produced from 06/07/2017 to 06/30/2017 at icam # 02.After analyzing this document, no records that could lead to the claimed defect were evidenced.Qn/ ncmr review: there are no quality notification (qn) or nonconformity report of "needle pulled out of hub¿ or anything that could lead to this complaint.Investigation conclusion: confirmed: bd was able to confirm the incident in question.Based on the investigations carried out, it can be determined that the root cause of the defect in question is due to a failure in the application and / or curing of the glue inside the hub, followed by a failure of pull off system which verifies that the needle of 100 % of parts are fixed into the hub.

• Brand Name: BD INSYTE¿
• 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: 7475624
• MDR Text Key: 107317702
• Report Number: 9610048-2018-00042
• Device Sequence Number: 1
• Product Code: FOZ
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 388312
• Device Lot Number: 7173852
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other