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 Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2018

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 with the use of the bd saf-t-intima¿ iv catheter safety system there was an issue with the stylet separating. It was stated ¿the safe t intima inserted into patient. No obvious error or issue with product at the time of insertion. On removing cannula from patient, it was noted that the needle was still in the plastic sheath and had remained present in the patient for the 24 hours. No change to patient care. ¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: one partial unit was received for analysis. Our quality engineer visually inspected the returned unit and confirmed that the needle was broken at the notch. We were unable to confirm the damage to the manufacturing process. Device history and quality records have been consulted for tracking and trending purposes and no issues like this are detected which means low occurrence. Product is functional tested in the manufacturing process, no incidents with separation stylet/needle has been reported. No corrective action required at the failure. Process was reviewed and there are proper controls in place to detect product malfunctions. Based on investigation results to date root cause cannot be determined. No capa was opened since this issue could not be confirmed as manufacturing related.

• 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: 7447483
• MDR Text Key: 106387699
• Report Number: 9610847-2018-00117
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 383323
• Device Lot Number: 7083683
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 04/20/2018 Patient Sequence Number: 1