MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM); INTERVASCULAR CATHETER

Catalog Number 383536

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that five bd nexiva dual port 20ga 1.00in (1.1 mm x 25 mm) experienced separation during use.The following information was provided by the initial reporter: material no: 383536, batch no: 9015970.Event description per customer email states: we have had five incidents in three weeks of the catheters disconnecting after insertion.We believe this might be isolated to lot number 9015970.20 gauge closed iv catheter system.

Event Description

It was reported that five bd nexiva dual port 20ga 1.00in (1.1 mm x 25 mm) experienced separation during use.The following information was provided by the initial reporter: material no: 383536, batch no: 9015970.Event description per customer email states, we have had five incidents in three weeks of the catheters disconnecting after insertion.We believe this might be isolated to lot number 9015970.20 gauge closed iv catheter system.

Manufacturer Narrative

Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM)
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8551136
• MDR Text Key: 146405956
• Report Number: 1710034-2019-00453
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

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
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 383536
• Device Lot Number: 9015970
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other