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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610847-2018-00118
• Device Sequence Number: 19175872
• Product Code: FOZ
• UDI-Device Identifier: 30382903833352
• UDI-Public: 30382903833352
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 383335
• Device Lot Number: 4148785
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other