MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383593
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.The customer's address is unknown.Washington, usa has been used as a placeholder based on the reported phone area code.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system tip broke off into the patient.No further information was provided.The following information was provided by the initial reporter: "reviewed with clinical team and that tip had broken off in patient.".
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system tip broke off into the patient.No further information was provided.The following information was provided by the initial reporter: "reviewed with clinical team and that tip had broken off in patient.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-feb-2023.H6: investigation summary: our quality engineer inspected the 2 samples submitted for evaluation.The reported issues of catheter tip integrity and catheter broke / separated after placement were not confirmed upon inspection of the samples.Analysis of the samples showed that one sample correspond to a catalog from nexiva diffusics 1.25¿, which matches the reported material number.The other sample provided corresponds to nexiva catalog 1.00¿.The sample which corresponded with the nexiva catalog 1.00¿ was returned opened and used.Bd could not determine a manufacturing related root cause since the samples returned met their respective manufacturing standards.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.A review of production records could not be performed since lot numbers were not supplied for the returned samples.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER 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: 16318637
• Report Number: 9610847-2023-00017
• Device Sequence Number: 18346289
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: 00382903835935
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K123734
• 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): 03/01/2023

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: Health Professional
• Device Catalogue Number: 383593
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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