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

Catalog Number	383518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.: 383518, batch no.: 9150812.It was reported that the bd nexiva¿ closed iv catheter system had the metal needle come off of the retractor grip.The following information was provided by the initial reporter: one of the traveler rns says they were using a 20ga 1.75inch nexiva (lot 9150812) and the metal needle came off of the retractor grip.I haven't had an issue but we do have a lot of that lot in stock.
Additional Manufacturer Narrative
Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record was performed and no quality issues were found during production.
Event or Problem Description
Material no.: 383518; batch no.: 9150812.It was reported that the bd nexiva¿ closed iv catheter system had the metal needle come off of the retractor grip.The following information was provided by the initial reporter: one of the traveler rns says they were using a 20ga 1.75inch nexiva (lot 9150812) and the metal needle came off of the retractor grip.I haven't had an issue but we do have a lot of that lot in stock.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9323560
• Report Number: 1710034-2019-01223
• Device Sequence Number: 16951289
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: 30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (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): 12/16/2019

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: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 383518
• Device Lot Number: 9150812
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other