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
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 was damaged causing leakage.The following information was provided by the initial reporter, translated from portuguese to english: there was a hole in device's extension, causing a blood leakage after puncture.
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 8 photos submitted for evaluation.The reported issues of tubing defective / damaged and leakage were not confirmed upon inspection of the photos.With the supplied photos it was not possible to clearly see any tubing damage or defects.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system was damaged causing leakage.The following information was provided by the initial reporter, translated from portuguese to english: there was a hole in device's extension, causing a blood leakage after puncture.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system was damaged causing leakage.The following information was provided by the initial reporter, translated from portuguese to english: there was a hole in device's extension, causing a blood leakage after puncture.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 06-sep-2023.H.6.Investigation summary: our quality engineer inspected the 8 photos and 1 sample submitted for evaluation.The reported issues of tubing defective / damaged and leakage were not confirmed upon inspection and testing of the sample photos and sample.Analysis of the sample photos did not show any damages or abnormalities on the sample in the photos.Analysis of the physical sample was performed, and no defects or damages were observed.The sample underwent leakage testing and passed with no defect observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.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.

• 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 ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17445610
• Report Number: 9610847-2023-00208
• Device Sequence Number: 16828102
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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: 06/30/2025
• Device Catalogue Number: 383336
• Device Lot Number: 1179659
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 09/20/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/30/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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