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

Model Number 383557

Device Problems Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354); Separation Problem (4043)

Patient Problem Pain (1994)

Event Date 02/08/2023

Event Type  Injury  

Event Description

It was reported that during use with bd nexiva¿ single port maxzero¿ closed iv catheter leakage occurred and tubing was discovered to be damaged.Patient had order from 4mg ivp of morphine but due to having to remove piv.Pain treatment was switched to tylenol 1000mg po.The following information was provided by the initial reporter: (1st of 3 occurrences).Patient was taken to ct (study was without contrast).Patient was brought back to emergency department and nurse noted bleeding from iv site.Iv was removed and secured.

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: foz.Common device name: intravascular catheter.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

After further review of the customer's event description, the following fields have been updated with corrections: b5: describe event or problem: it was reported that during use with bd nexiva¿ single port maxzero¿ closed iv catheter separated from hub and leakage occurred.Patient had order from 4mg ivp of morphine but due to having to remove piv.Pain treatment was switched to tylenol 1000mg po.H6: imdrf annex a grid: a1503, a0504.

Event Description

It was reported that during use with bd nexiva¿ single port maxzero¿ closed iv catheter catheter separated from hub and leakage occurred.Patient had order from 4mg ivp of morphine but due to having to remove piv.Pain treatment was switched to tylenol 1000mg po.The following information was provided by the initial reporter: (1st of 3 occurrences) patient was taken to ct (study was without contrast).Patient was brought back to ed and nurse noted bleeding from iv site.Iv was removed and secured.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-mar-2023.H.6.Investigation summary: our quality engineer inspected the representative samples and photographs submitted for evaluation.Bd received 642 sealed 20g x 1.25in.Nexiva units from lot number 2250144.Additionally, three photos were provided for investigation.The photo labeled ¿unknown incident.Png¿ displayed a used 20g nexiva unit.The extension tubing was not visible however it is evident that it was separated from the catheter adapter.No tubing remnants can be seen inside the catheter adapter, ruling out the possibility that the tubing was severed.Therefore, it is likely that the tubing separated due to a lack of adequate adhesion between the extension tubing and catheter adapter.Both photos show a used 20g nexiva unit.In both units the extension tubing can be seen separated from the catheter adapter.The end of the extension tubing appears undamaged, and no tubing remnants can be seen inside the catheter adapter.This evidence rules out the possibility that the tubing was severed.Therefore, it is likely that the tubing separated due to a lack of adequate adhesion between the two components.A gross visual inspection of the returned units did not identify any damage to the components.A sampling of 125 units were inspected.To verify that the extension tubing was adequately adhered to the catheter adapter, the units were first leak tested.During removal of the units from the sealed packaging, two units had the extension tubing separate from the catheter adapter when lightly pulled on the extension tubing.During leak testing, one unit immediately separated upon flushing.All other units passed leak testing.Given the ease with which the defective units separated, it is likely that no adhesive was present on the components.This was verified by microscopic inspection which found no traces of adhesive on the extension tubing or inside port of the winged adapter.This indicates that adhesive was not dispensed properly during manufacturing and thus failed to adhere the two components together.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that during use with bd nexiva¿ single port maxzero¿ closed iv catheter catheter separated from hub and leakage occurred.Patient had order from 4mg ivp of morphine but due to having to remove piv.Pain treatment was switched to tylenol 1000mg po.The following information was provided by the initial reporter: (1st of 3 occurrences).Patient was taken to ct (study was without contrast).Patient was brought back to ed and nurse noted bleeding from iv site.Iv was removed and secured.

• Brand Name: BD NEXIVA¿ SINGLE PORT MAXZERO¿ CLOSED IV CATHETER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16492949
• MDR Text Key: 310780896
• Report Number: 1710034-2023-00187
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903835578
• UDI-Public: (01)30382903835578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383557
• Device Catalogue Number: 383557
• Device Lot Number: 2250144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other