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	383322
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1 initial reporter phone #: (b)(6).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 experienced a crack causing leakage.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, when the nurses of the general department performed the operation and treatment of the patient's intravenous indwelling needle, the operation process was smooth, and the needle core was withdrawn in one step, and there was no process of the needle tip staying in the hose.When the indwelling tube was flushed after indwelling, it was found that the end of the indwelling tube leaked.After careful inspection, a crack was found in the tube.
Additional Manufacturer Narrative
H6: investigation summary: it was reported there was a crack in the indwelling tube.As no photo or sample was returned for evaluation, a thorough sample investigation could not be completed.This product was made manually.During the assembly process and in the packaging area, product quality is evaluated during the manufacturing process with inspections.This inspection is performed 100% by operators to ensure that the product met acceptance criteria.Control technicians also perform a sampling according to the quality control plan.The device history record was reviewed, and no quality notifications 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.Based on the investigation results, bd was not able to confirm the indicated failure mode.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced a crack causing leakage.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, when the nurses of the general department performed the operation and treatment of the patient's intravenous indwelling needle, the operation process was smooth, and the needle core was withdrawn in one step, and there was no process of the needle tip staying in the hose.When the indwelling tube was flushed after indwelling, it was found that the end of the indwelling tube leaked.After careful inspection, a crack was found in the tube.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16740470
• Report Number: 9610847-2023-00085
• Device Sequence Number: 12437385
• Product Code: FOZ
• UDI-Device Identifier: 00382903833221
• UDI-Public: 00382903833221
• 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): 04/19/2023

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: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 383322
• Device Lot Number: 1327374
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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