MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383323

Device Problems Device Operates Differently Than Expected (2913); Scratched Material (3020)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

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 safety mechanism on a bd saf-t-intima¿ iv catheter safety system failed to function properly, leaving the dirty needle exposed.There was report of exposure, injury or medical interventions.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence.A review of the device history records revealed no irregularities during the manufacture of reported lot number 7004940.This product is functionally tested by qa tech in final assembly and, no failure with safety mechanism or exposed cannula was reported.According to the information provided by the customer, we could not associate this defect to a manufacturing process.However, a possible cause could be an incorrect use of the product.The only way to reproduce this defect is to perform the activation from adapter sti prn, removing all safety mechanism and leaving exposed cannula.Instruction sheet (b)(4), shows the correct way to perform this activation.No capa was opened since this issue could not be confirmed as manufacturing related.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7475616
• MDR Text Key: 107517870
• Report Number: 9610847-2018-00096
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• 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: 05/02/2018

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: Nurse
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 383323
• Device Lot Number: 7004940
• 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