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	03/10/2023
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 a crack in the bd saf-t-intima¿ iv catheter safety system extension tubing caused fluid to leak out during use.This occurred with 5 catheters.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2023, after the indwelling needle was punctured for the patient, the nurse in the burn department found that there was a crack in the extension tube, which led to fluid leakage.This has happened many times recently, resulting in the need for re-puncture.The patient was very dissatisfied, and the head nurse hoped to avoid this situation.".
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 video submitted for evaluation.The reported issue of leakage at inserter / tubing was confirmed upon inspection of the video.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr for this lot was reviewed and there are no internal rejects related to the reported issue by the customer.H3 other text : see h10.
Event or Problem Description
It was reported that a crack in the bd saf-t-intima¿ iv catheter safety system extension tubing caused fluid to leak out during use.This occurred with 5 catheters.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2023, after the indwelling needle was punctured for the patient, the nurse in the burn department found that there was a crack in the extension tube, which led to fluid leakage.This has happened many times recently, resulting in the need for re-puncture.The patient was very dissatisfied, and the head nurse hoped to avoid this situation.".

• 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: 16637545
• Report Number: 9610847-2023-00075
• Device Sequence Number: 12121316
• 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): 04/20/2023

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: 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: 03/11/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/07/2023
• 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