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

Catalog Number 383322

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.No serious injury or medical intervention was reported.

Event Description

It was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.This occurred on 2 separate occasions but the date/time and or patient information is unknown.No serious injury or medical intervention was reported.

Manufacturer Narrative

Describe event or problem: it was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.This occurred on 2 separate occasions but the date/time and or patient information is unknown.No serious injury or medical intervention was reported.Investigation summary: a device history review was conducted for lot number 7300727.Our records show the reported lot was manufactured on 11/23/2017 and determined that this is the only instance of defective tubing 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.Unfortunately the photograph submitted could not assist our engineers in the identification of the failure mode, and without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8203614
• MDR Text Key: 131711922
• Report Number: 9610847-2018-00454
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833222
• UDI-Public: 30382903833222
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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: Health Professional
• Device Catalogue Number: 383322
• Device Lot Number: 7300727
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other