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 383313

Device Problems Break (1069); Material Separation (1562); Device Fell (4014)

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

Event Date 07/09/2018

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 during the use of the bd saf-t-intima¿ iv catheter safety system the needle broke in half.It was further clarified that when pulling the shield, the needle broke while still in the patient's arm and the needle separated from the guide wire when pulling out the shield.While removing the catheter, the needle also came out of the patient's arm as well.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.The device history report for lot number 6243927 was reviewed, no related abnormalities were found.Material number (b)(4) for lot 6243927was manufactured on 08/31/2016.This is the first instance of these failure modes 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.A sample was provided for the purpose of aiding our quality engineer's investigation, during evaluation the devices were determined to have broken tubing, bent needles, and a separation between the stylet and needle components.Bd engineers determine the root cause for this event to be related to product use, this conclusion was reached after visual evaluation of the device identified a cut in the tubing that was consistent with slide clamp damage.Once the tubing was lacerated the clamp may have contributed to the damage in the stylet.The bent needle observed by the bd investigators was most likely the result of transportation damage during the return of the sample.Bd will continue to track and trend for this issue.No corrective action was performed since this issue could not be confirmed as manufacturing related.

Event Description

It was reported that during the use of the bd saf-t-intima iv catheter safety system the needle broke in half.It was further clarified that when pulling the shield, the needle broke while still in the patient's arm and the needle separated from the guide wire when pulling out the shield.While removing the catheter, the needle also came out of the patient's arm as well.There was no report of exposure, serious injury or medical intervention.

• 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: 7735333
• MDR Text Key: 115670526
• Report Number: 9610847-2018-00231
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383313
• Device Lot Number: 6243927
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other