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

Model Number	383312
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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 24 ga 0.75 in leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: on may 19, the nurse gave the inpatient an infusion, and the exhaust inspection tube was normal.After the puncture was successful, the 3m transparent applicator was fixed.About 30 minutes later, during the inspection of the infusion process, a little liquid was found on the back of the patient's hand, and the patient carefully observed that there was liquid at the plastic hose of the patient's indwelling needle.After communicating with the patient, it is recommended to re-puncture.The patient and his family members require the tape to be fixed after disinfection, and temporarily retain it after checking for no bleeding.
Additional Manufacturer Narrative
H6: investigation summary : our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of leakage at inserter / tubing was not confirmed upon inspection of the photo.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.According to the quality records all the inspections of the sampling plan met the acceptance criteria.
Event or Problem Description
It was reported while using bd saf-t-intima¿ safety system with removable prn 24 ga 0.75 in leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: on may 19, the nurse gave the inpatient an infusion, and the exhaust inspection tube was normal.After the puncture was successful, the 3m transparent applicator was fixed.About 30 minutes later, during the inspection of the infusion process, a little liquid was found on the back of the patient's hand, and the patient carefully observed that there was liquid at the plastic hose of the patient's indwelling needle.After communicating with the patient, it is recommended to re-puncture.The patient and his family members require the tape to be fixed after disinfection, and temporarily retain it after checking for no bleeding.

• 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 ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17205250
• Report Number: 9610847-2023-00158
• Device Sequence Number: 17527880
• 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
• Report Date (Section B): 06/30/2023

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: 03/31/2026
• Device Model Number: 383312
• Device Catalogue Number: 383312
• Device Lot Number: 2067693
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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