MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I; INTRAVASCULAR CATHETER

Model Number 383313

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event Description

It was reported that the bd saf-t-intima w/y adapter yel 24ga x.75i experienced leakage.The following information was provided by the initial reporter: "the patient has leakage after puncture.

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.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 01-sep-2022.Investigation summary: our quality engineer inspected the 1 sample and 2 photos submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the samples.Bd determined that the cause of the failure cannot be associated to the manufacturing process since there are several non-manufacturing related causes that could have resulted in this failure.Production records were reviewed, and this batch was in compliance with our product specification requirements.A notification was sent to the proper manufacturing personnel to inform them of the defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd saf-t-intima w/y adapter yel 24ga x.75i experienced leakage.The following information was provided by the initial reporter: "the patient has leakage after puncture.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
• 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 ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15178963
• MDR Text Key: 300708862
• Report Number: 9610847-2022-00289
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 1139436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1