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

Catalog Number 383313

Device Problems Loose or Intermittent Connection (1371); Retraction Problem (1536)

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

Event Date 08/15/2018

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 a bd saf-t-intima iv catheter safety system had needle retraction failure. The needle hung loosely and failed to retract after use. There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

A device history report was conducted for lot number 7349714, and no related abnormalities were found. This lot of saf-t-intima w/adapter was manufactured on (b)(6) 2018, and this is the first instance of this complication occurring in this lot. 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 photograph was provided for the purpose of aiding our quality engineer's investigation, however the photograph was unable to provide any insights into the issue reported by your facility. Bd engineers reviewed the manufacturing process and the associated procedures, but were unable to associate this issue with the manufacturing process. No corrective action was performed since this issue could not be confirmed as manufacturing related. Bd will continue to track and trend for this issue.

Event Description

It was reported that a bd saf-t-intima iv catheter safety system had needle retraction failure. The needle hung loosely and failed to retract after use. There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY 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: 7852081
• MDR Text Key: 119535600
• Report Number: 9610847-2018-00294
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 383313
• Device Lot Number: 7349714
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/06/2018 Patient Sequence Number: 1