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 383336

Device Problem Material Perforation (2205)

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

Event Date 08/18/2018

Event Type  malfunction  

Manufacturer Narrative

Reporter phone#: (b)(6).Occupation: (b)(6) - nucleus of technical support and pharmaceutical education.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 perforation occurred in the extension of the bd saf-t-intima¿ iv catheter safety system during use.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that perforation occurred in the extension of the bd saf-t-intima¿ iv catheter safety system during use.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: the device history report for lot number 7083685 was reviewed, no related abnormalities were found.Material number 383336 for lot 7083685 was manufactured on april 21, 2017.This is the first instance of this failure mode with this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Unfortunately a sample could not be obtained for the purpose of the investigation.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.However, bd will continue to monitor this issue.

• 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: 7889192
• MDR Text Key: 120973205
• Report Number: 9610847-2018-00307
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833369
• UDI-Public: 30382903833369
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 383336
• Device Lot Number: 7083685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other