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	383336
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
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 safety mechanism failure.The following information was provided by the initial reporter, translated from portuguese to english: an attempt was made in obs room 13 to install a peripheral venous access, with intima 20 from the bd salf-t-intima brand, in which during the catheter insertion procedure, the safety device failed, because when trying to remove the needle, even pressing the fixation wing, the catheter was removed completely with silicone and exposed needle passing under the professional's finger, without occurrence of an accident at work.
Additional Manufacturer Narrative
H.6.Investigation summary: it was reported the safety device failed.As a sample was not returned, a through sample investigation could not be completed.It is recommended to provide the defective sample or photo for a further investigation of the indicated defect and find the root cause to prevent reoccurrence of this defect at the end of user facility.A device history record review was completed for provided material number 383336, lot 2122684.The review revealed there were 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.Based on the investigation, bd was not able to confirm the by customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced safety mechanism failure.The following information was provided by the initial reporter, translated from portuguese to english: an attempt was made in obs room 13 to install a peripheral venous access, with intima 20 from the bd salf-t-intima brand, in which during the catheter insertion procedure, the safety device failed, because when trying to remove the needle, even pressing the fixation wing, the catheter was removed completely with silicone and exposed needle passing under the professional's finger, without occurrence of an accident at work.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17436296
• Report Number: 9610847-2023-00205
• Device Sequence Number: 18363993
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/08/2023

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: 04/30/2026
• Device Catalogue Number: 383336
• Device Lot Number: 2122684
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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