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

Catalog Number	383322
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported while using bd saf-t-intima¿ safety system with removable prn 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: when the nurse in the thyroid and breast surgery ward placed an intravenous indwelling needle on the patient, he found suspicious floc on the tip of the indwelling needle.2.Adverse events: there is foreign matter in the needle of the indwelling needle and cannot be used.3.Impact on victims: it has not been used on patients and has no impact.4.Treatment measures taken and results: immediately replace the indwelling needle and carefully check whether the indwelling needle is intact before each operation to avoid harm to the patient.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number: 383322 and lot number: 2067695.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.
Event or Problem Description
It was reported while using bd saf-t-intima¿ safety system with removable prn 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: when the nurse in the thyroid and breast surgery ward placed an intravenous indwelling needle on the patient, he found suspicious floc on the tip of the indwelling needle.2.Adverse events: there is foreign matter in the needle of the indwelling needle and cannot be used.3.Impact on victims: it has not been used on patients and has no impact.4.Treatment measures taken and results: immediately replace the indwelling needle and carefully check whether the indwelling needle is intact before each operation to avoid harm to the patient.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN
• Common Device Name: INTERVASCULAR 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17872893
• Report Number: 9610847-2023-00275
• Device Sequence Number: 5761562
• Product Code: FOZ
• UDI-Device Identifier: 30382903833222
• UDI-Public: (01)30382903833222
• 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
• Report Date (Section B): 10/11/2023

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: 02/28/2026
• Device Catalogue Number: 383322
• Device Lot Number: 2067695
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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