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

Catalog Number 383312

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

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 bd saf-t-intima¿ integrated safety catheter system leaked at the tubing joint.

Event Description

It was reported that the bd saf-t-intima¿ integrated safety catheter system leaked at the tubing joint.This occurred on 2 separate occasions but the date/time and or patient information is unknown.

Manufacturer Narrative

It was reported that the bd saf-t-intima¿ integrated safety catheter system leaked at the tubing joint.This occurred on 2 separate occasions but the date/time and or patient information is unknown.A device history review was conducted for lot number 7327621.Our records show that this is the only instance of leakage occurring in this batch of saf-t-intima.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.The sample returned was subjected to leakage testing under the limits established by the product specification.The results from this experiment found the device to be operating within the established limits without evidence of a leak in the unit.Based on these results, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER 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: 8204623
• MDR Text Key: 131783320
• Report Number: 9610847-2018-00445
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: 30382903833123
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: 383312
• Device Lot Number: 7327621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other