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

Catalog Number 38183414

Device Problem Split (2537)

Patient Problem Injury (2348)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the catheter of a bd insyte¿ autoguard¿ shielded iv catheter split at the time of iv insertion.It was also reported that "these traumas were treated with the use of mucopolysaccharide polysulfate".

Manufacturer Narrative

It has been determined that the event repoted on the intial mdr is not reportable and has therefore been over-reported.

• 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: 7451286
• MDR Text Key: 106188901
• Report Number: 9610048-2018-00045
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 38183414
• Device Lot Number: 7262990
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention