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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
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.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported by the customer that 3 of the bd saf-t-intima¿ iv catheter safety system were broken.The following information was provided by the initial reporter: reached out to her omitted rep regarding broken saf-t-intima items today.Item# 383336 we spoke on the phone and said maddi is hoping to get on the phone with an omitted rep today.Omitted said ¿possibly 4 or 5¿ broken today.
Event or Problem Description
It was reported by the customer that 3 of the bd saf-t-intima¿ iv catheter safety system were broken.The following information was provided by the initial reporter: reached out to her omitted rep regarding broken saf-t-intima items today.Item# 383336 we spoke on the phone and said maddi is hoping to get on the phone with an omitted rep today.Omitted said ¿possibly 4 or 5¿ broken today.
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of adapter / connector defective / damaged was confirmed upon inspection of the photo.Analysis of the sample showed that the sample in the photo was missing threading on the adapter.Bd determined that the cause of the failure was related to a molding error in our supplier¿s process.No dhr review was performed since the customer did not provide a batch number to report.H3 other text : see h10.

• 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: 15970434
• Report Number: 9610847-2022-00468
• Device Sequence Number: 5573622
• Product Code: FOZ
• UDI-Device Identifier: 50382903833363
• UDI-Public: 00382903833368
• 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): 02/16/2023

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 Catalogue Number: 383336
• Device Lot Number: UNKNOWN
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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