MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number	383312
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd saf-t-intima¿ safety system with removable prn 24 ga 0.75 in foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: 1.Specific operation and usage: on september 22, when the nurse in the department of infectious diseases and hepatology was preparing to perform venipuncture on the patient, he found a small amount of foreign matter at the tip of the intravenous indwelling needle.2.Adverse events: there is foreign matter in the needle of the indwelling needle and cannot be used.3.Impact on victims: no use on patients, no impact 4.Treatment measures taken and results: replace with a new indwelling needle and report to the medical engineering department.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 383312 and lot number 2089814.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.
Event or Problem Description
No additional information recevied.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 383312 and lot number 2089814.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information received.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 24 GA 0.75 IN
• 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 UT ; MX
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17935230
• Report Number: 1710034-2023-01198
• Device Sequence Number: 20425145
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: (01)30382903833123
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/05/2024

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: 03/31/2026
• Device Catalogue Number: 383312
• Device Lot Number: 2089814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 01/02/2024; 01/02/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/02/2024; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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