MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVENOUS CATHETER

Catalog Number	383336
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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.
Additional 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.
Event or Problem 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.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Common Device Name: INTRAVENOUS 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: 16369148
• Report Number: 9610847-2023-00027
• Device Sequence Number: 18103917
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K923702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 383336
• Device Lot Number: 1292631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown