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

Catalog Number 383532

Device Problems Detachment Of Device Component (1104); Sticking (1597)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter email: (b)(6).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 when inserting the bd nexiva¿ closed iv catheter system, the needle did not detach from the iv line once inserted.It retracted fully but remained stuck.We ended up having to remove the (successful) iv we had just inserted because we physically couldn¿t get the needle detached.Once the iv line was out of the patient, it took great force/pulling to actually detach the needle.Found during use.No reports of serious injury or medical intervention noted.

Event Description

It was reported that when inserting the bd nexiva¿ closed iv catheter system, the needle did not detach from the iv line once inserted.It retracted fully but remained stuck.We ended up having to remove the (successful) iv we had just inserted because we physically could not get the needle detached.Once the iv line was out of the patient, it took great force/pulling to actually detach the needle.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that when inserting the bd nexiva¿ closed iv catheter system, the needle did not detach from the iv line once inserted.It retracted fully but remained stuck.We ended up having to remove the (successful) iv we had just inserted because we physically couldn¿t get the needle detached.Once the iv line was out of the patient, it took great force/pulling to actually detach the needle.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for investigation, bd was unable to confirm the reported issue as well as fully investigate this incident.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Investigation conclusion: root cause is indeterminate.Comment: the alleged defect described in the product incident report was not confirmed or replicated; as units were not provided for this incident, therefore a definite root cause could not be established.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7602171
• MDR Text Key: 111678202
• Report Number: 1710034-2018-00318
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835324
• UDI-Public: 00382903835324
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

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
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383532
• Device Lot Number: 7290663
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 05/24/2018; 05/24/2018
• Supplement Dates FDA Received: 07/31/2018; 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other