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 Mechanical Problem (1384)

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

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). 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 of the bd saf-t-intima¿ iv catheter safety system failed to work after the puncture.

Event Description

It was reported that the safety mechanism of the bd saf-t-intima¿ iv catheter safety system failed to work after the puncture.

Manufacturer Narrative

A device history review was conducted for lot number 7327618. Our records show the reported lot was manufactured on 12/04/2017; it was determined that this is the third instance of a needle retraction failure occurring in this production batch. According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections. A sample could not be obtained for evaluation and testing. Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint. Bd was able to duplicate the customer¿s indicated failure mode performing an incorrect activation from safety device, if user after having done correctly the insertion, upon pulling back on safety device it is performed since adapter clear prn and puller sti, removing all safety device and leaving exposed cannula. Currently, there is a sampling plan in place lot by lot to look for this kind of defect and according to internal process rejects (qn¿s) database, no issues like this have been reported. Dhr review for lot reported of catalog 383323, all samples taken for visual and functional characteristics properly met the acceptance criteria. We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary. Pfmea¿s 4797 and p-eura rm5942 was reviewed and process controls are very likely to detect failure modes and prevent failures end users.

• 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: 8096306
• MDR Text Key: 128198124
• Report Number: 9610847-2018-00390
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 383323
• Device Lot Number: 7327618
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/21/2018 Patient Sequence Number: 1