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 383335

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 leakage.The customer stated ¿there was a hole found on the tubing which was causing saline and blood to leak out.Had to re-stick the patient due to the issue with the product.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

H.6.Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Customer reported damaged / leakage issues; however, no sample was available for evaluation which is essential to perform a better investigation.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means pretty low occurrence.Product is functional tested and no incidents with damaged or leakage have been reported.Reviewing our pfmea¿s, rm4797 there are proper controls in place to detect product malfunctions.Always refer to ifu for product usage recommendations.Sample is required to confirm/discard this kind of problems.Investigation conclusion: without sample or photo defective we cannot to determinate the root cause.

• 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: 7451459
• MDR Text Key: 106387312
• Report Number: 9610847-2018-00118
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833352
• UDI-Public: 30382903833352
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 383335
• Device Lot Number: 4148785
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other