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

Catalog Number	383518
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	03/26/2018
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, a supplemental report will be filed.
Event or Problem Description
It was reported that the  bd nexiva¿ closed iv catheter single-port system had a kink near the hub at the end of the extension set prior to use.When started, blood leaked out where the initial kink was.Found during use.Expsure to blood/ bodily fluid was reported however, no reports of medical intervention or serious injury was noted.
Additional Manufacturer Narrative
Investigation summary: dhr review: a review of the dhr could not be performed as no batch information was provided.Qn database review: a review of the qn database could not be performed as no batch information was provided.Sample analysis: examination of the returned device revealed kinked extension tubing at the catheter adapter port.This is consistent with the customer's verbatim description of the device being broken next to the wing.The customer's experience was confirmed.Investigation conclusion: this defect occurs during the manufacturing process on zone 7 at the adhesive dispense station if the luer adapter is misaligned during the insertion of the extension tube.Current process controls include leak testing after zone 9 at regular intervals, as well as a 100% inspection system for tubing seat depth.Project s17-044 redesigned the adhesive dispense stations on both zone 7 and zone 8, allowing for more control of the extension tube during the insertion process into the adapter.This increased control is expected to reduce this defect.Note: it is unknown when this nexiva unit was built in respect to the implementation, as a batch/lot number was not provided for this incident.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SINGLE-PORT SYSTEM
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7422340
• Report Number: 1710034-2018-00169
• Device Sequence Number: 10799425
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: 00382903835188
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K161777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: 383518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/08/2018
• 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