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 Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence.Without defective sample or photo for us is very difficult to determinate the root of cause, however; according with provided information by customer this defect could be related with an incorrect activation of the device.We were not able to associate the reported defect to the mfg.Process.Conclusion: this reported defect could be related with an incorrect use of the device by user.If after finished the puncture the user performed the device activation since adapter sti prn, all the safety mechanism is removing, causing exposed cannula.Dhr did not showed evidence of an issue related to the reported by customer.P-eura rm5942 show the procedures used to assemble this product.No capa was opened since this issue could not be confirmed as manufacturing related.

Event Description

It was reported during use of the bd saf-t-intima¿ iv catheter safety system when finished with the puncture, the needle was withdrawn and the security device didn´t activated leaving the needle exposed.There was no report of injury or medical intervention.

Manufacturer Narrative

Date received by manufacturing correction.The date received by manufacturer field has been updated to reflect the corrected date of 11/09/2017.

• 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: 7079297
• MDR Text Key: 94807632
• Report Number: 9610847-2017-00168
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: 00382903833238
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 383323
• Device Lot Number: 7083683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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