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	383592
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device lot #: lot# 308803 was reported, however, this is not a lot # manufactured for the reported catalog # 383592.D.4 device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system broke.The following information was provided by the initial reporter: the patient went to the bathroom, wiped and the iv snapped at the catheter hub leaving the catheter in the patient¿s vein.Additional information received on 16-july-2023.I was out of the office sick last week.See below product compliant from (b)(6).Contact is (b)(6).(b)(6) recently had an incident with the bd diffusics 20g catheter, lot# 308803.The patient went to the bathroom, wiped and the iv snapped at the catheter hub leaving the catheter in the patient¿s vein.Product was not kept for review.I would like to submit a formal concern related to this.Have there been reports of like occurrence or lot issues reported?.
Additional Manufacturer Narrative
Investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system broke.The following information was provided by the initial reporter: the patient went to the bathroom, wiped and the iv snapped at the catheter hub leaving the catheter in the patient¿s vein.Additional information received on 16-july-2023 i was out of the office sick last week.See below product compliant from st joes in bellingham, wa.Contact is michelle henderson.St.Joe¿s recently had an incident with the bd diffusics 20g catheter, lot# 308803.The patient went to the bathroom, wiped and the iv snapped at the catheter hub leaving the catheter in the patient¿s vein.Product was not kept for review.I would like to submit a formal concern related to this.Have there been reports of like occurrence or lot issues reported?.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17421331
• Report Number: 9610847-2023-00198
• Device Sequence Number: 9025475
• Product Code: FOZ
• UDI-Device Identifier: 30382903835929
• UDI-Public: (01)30382903835929
• 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): 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 383592
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown