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 Problem Defective Device (2588)

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

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).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 defect occurred with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, "the catheter is with defect during puncture.Information received by email on 4/15/2019: the customer informed that the catheter presents defect during the punction.The incident was noticed during the use.There was no damage to the patient/health professional.There was no exposure of blood or chemotheraputic to the skin.".

Event Description

It was reported that a defect occurred with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: "the catheter is with defect during puncture.Information received by email on 4/15/2019: the customer informed that the catheter presents defect during the punction.The incident was noticed during the use.There was no damage to the patient/health professional.There was no exposure of blood or chemotherapic to the skin.".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 7349713.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.Additionally the sample provided was reviewed and found to have an incorrect lie distance.The most likely root cause for this event could not be confirmed due to the state of the packaging upon arrival, however transportation and storage of the device can produce the reported failure mode.Based on investigation results to date, the root cause cannot be determined to manufacturing process.Catheter not showed damages.

• 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: 8564995
• MDR Text Key: 145946534
• Report Number: 9610847-2019-00339
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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: 7349713
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other