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 Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.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 that the safety mechanism on a bd saf-t-intima¿ iv catheter safety system didn¿t function properly.There was no report of injury or medical interventions.

Manufacturer Narrative

Results: bd received one sample from the customer in support of this complaint.After evaluating the sample we cannot confirm or associate the reported defect to the mfg.Process, because safety device received with exposed cannula was activated without problems according ifu d12556.This reported defect could be related with an incorrect use of the product by user.A possible cause is that after of finishing the puncture, user performed the activation since adapter sti prn, removing all the safety mechanism and leaving exposed cannula.Instruction sheet d12556, show correct way to perform this activation.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Bd was not able to duplicate or confirm the customer's indicated failure mode.Based on investigation results to date, root cause for manufacturing process cannot be determined, however a possible cause could be the use incorrect of the device by user.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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7059411
• MDR Text Key: 93722010
• Report Number: 9610847-2017-00156
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383323
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other