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

Catalog Number 383312

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 03/04/2019

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 extension tubing of a bd saf-t-intima¿ iv catheter safety system with prn adapter was broken from the wing, and the catheter was out of vein.Customer¿s verbatim: ¿ event date: (b)(6) 2019.The catheter was placed on (b)(6) 2019 successfully.It's noticed that the catheter was out of vein, and extension tubing was broken from the wing.The catheter was removed immediately.¿.

Event Description

It was reported that the extension tubing of a bd saf-t-intima¿ iv catheter safety system with prn adapter was broken from the wing, and the catheter was out of vein.Customer¿s verbatim: ¿ event date: (b)(6) 2019.The catheter was placed on (b)(6) 2019 sucessfully.It's noticed that the catheter was out of vein, and extension tubing was broken from the wing.The cather was removed immediately.¿.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 7208546.Our records show that this is the only instance of this issue 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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately without the affected sample, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER
• 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: 8436744
• MDR Text Key: 139443824
• Report Number: 9610847-2019-00234
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 383312
• Device Lot Number: 7208546
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other