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 383336

Device Problem Air/Gas in Device (4062)

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

Event Date 01/19/2023

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 bd saf-t-intima¿ iv catheter safety system experienced air bubbles.The following information was provided by the initial reporter: the two catheters had the same issue during our ozone treatment causing a lot of bubbles.

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system experienced air bubbles.The following information was provided by the initial reporter: the two catheters had the same issue during our ozone treatment causing a lot of bubbles.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 13-mar-2023.H6: investigation summary: our quality engineer inspected the 23 samples and 2 photos submitted for evaluation.The reported issue of air bubbles / air in line was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that there were no abnormalities or damages to the samples.The samples were tested for the reported defect and all of the samples passed testing.Bd could not determine a root cause since the reported defect was not confirmed during the sample evaluations.Production records were reviewed, and this batch met our manufacturing product specification requirements.

• 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 ; 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: 16369151
• MDR Text Key: 309467383
• Report Number: 9610847-2023-00026
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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: Other
• Device Catalogue Number: 383336
• Device Lot Number: 1292631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• 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