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

Model Number	383336
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced a loose needle, and the needle being unable to disengage.The following information was provided by the initial reporter: we had a rn start an iv using this product and the sharp did not retract appropriately.Instead it was loose from the receptacle.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: since no photos or samples displaying the reported condition of needle retraction failure were available for examination, we were unable to fully investigate this incident.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.H3 other text : see h10.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced a loose needle, and the needle being unable to disengage.The following information was provided by the initial reporter: we had a rn start an iv using this product and the sharp did not retract appropriately.Instead it was loose from the receptacle.

• 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 ; 8015296192
• MDR Report Key: 16018350
• Report Number: 9610847-2022-00493
• Device Sequence Number: 5859133
• Product Code: FOZ
• UDI-Device Identifier: 30382903833369
• UDI-Public: 30382903833369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 02/28/2026
• Device Model Number: 383336
• Device Catalogue Number: 383336
• Device Lot Number: 2066440
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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