MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿; INTRAVASCULAR CATHETER

Catalog Number	383551
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ the needle detached.The following information was provided by the initial reporter: cite customer ref# (b)(4) concern description: protective grey cover did not stay on needle once needle was withdrawn from patient, resulting in rn being stuck by needle.Safety device did not operate as it should occurrences: 1 each.Date of event: (b)(6) 2023.What procedure was being performed? peripheral iv insertion.What medication was used in the procedure? nil.Was there any medical intervention due to needle stick injury on rn? rn checked in to ed for first aid and triage (unsure what level of bbf she was considered).Is sample available for return to bd for investigation? if yes, please provide the sender¿s name and address for us to create the fedex return label.If sample is not available, are you able to provide photo(s) of the sample?.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ the needle detached.The following information was provided by the initial reporter: **cite customer (b)(4)** concern description: protective grey cover did not stay on needle once needle was withdrawn from patient, resulting in rn being stuck by needle.Safety device did not operate as it should occurrences: 1 each - date of event: (b)(6) 2023 - what procedure was being performed? peripheral iv insertion - what medication was used in the procedure? nil - was there any medical intervention due to needle stick injury on rn? rn checked in to ed for first aid and triage (unsure what level of bbf she was considered) - is sample available for return to bd for investigation? if yes, please provide the sender¿s name and address for us to create the fedex return label.
Additional Manufacturer Narrative
H.6.Investigation summary: a physical sample was not available for investigation but bd was provided with two photos of the issue for evaluation.A review of the device history record was performed for the reported lot, 3010198, and no quality issues were found during production.Our quality engineer reviewed the provided photos and observed that the tip shield was not present in the provided photos.Additionally, it appeared that the needle had become completely separated from the tip shield safety mechanism.There was no visible damage or defect to the needle.Therefore, based off the provided photos the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for evaluation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17753130
• Report Number: 1710034-2023-01056
• Device Sequence Number: 15116895
• Product Code: FOZ
• UDI-Device Identifier: 30382903835516
• UDI-Public: (01)30382903835516
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• 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): 10/04/2023

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 383551
• Device Lot Number: 3010198
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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